Nervous System Diseases

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Parkinson Disease

Central Nervous System Diseases

Movement Disorders

Ganglion Cysts

Synovial Cyst

Neurodegenerative Diseases

Basal Ganglia Diseases

Cysts

Parkinsonian Disorders

Brain Diseases

Synucleinopathies

Mucinoses

Connective Tissue Diseases

Patients in the GPi group will be implanted with DBS-electrodes within 6 weeks after randomisation. The stimulation parameters and the medical treatment are adjusted for optimal control of motor and non-motor signs and symptoms according to published guidelines using a specified algorithm. The stimulation parameters are recorded at the beginning and at the end of each post-surgical assessment.

Best medical treatment is applied in combination with GPi-DBS.

Deep brain stimulation (DBS) of Globus Pallidus internus (GPi) and Best medical treatment (BMT)

Patients will receive optimized medical treatment according to published evidence based guidelines.

Best medical treatment

Michael Schüpbach, PD Dr. med

Ines Debove, Dr. med

Deep brain stimulation (DBS) is an established treatment for advanced complicated Parkinson's disease (PD). Several controlled randomized studies have given proof of an advantage for operated patients as compared to medically treated patients in terms of motor outcome, activities of daily living and health status. However these studies have addressed mostly stimulation of the subthalamic nucleus (STN). GPi stimulation has not been compared to best medical treatment (BMT) in a prospective randomized controlled trial in patients with complicated PD who are not good candidates for STN stimulation. The investigators aim assessing GPi-DBS in patients with PD who have contraindications for STN-DBS.

The indication and excellent therapeutic effects of STN stimulation have been sufficiently proven in advanced PD, and the contraindications for this treatment are rather well established. Also, the observation that patients fulfilling the "STN-profile" but who had been operated for pallidal DBS and lost part of the treatment's benefit over time, improved when stimulated later in the STN (instead of the GPi) shows that patients qualifying for STN-DBS do not have as good a result with GPi-DBS.

GPi stimulation may be used in patients who do not qualify for STN stimulation. Especially postural instability, age over 70 years, and mild to moderate cognitive deficits are commonly considered to be exclusion criteria for STN stimulation but not for GPi stimulation. Therefore, the investigators propose a prospective randomized controlled trial of GPi stimulation in patients with PD and motor complications who have relative or absolute contraindications for STN stimulation.

Bilateral Pallidal Stimulation in Patients With Advanced Parkinson's Disease-LATESTIM

A Prospective Randomized Controlled Trial of Bilateral Pallidal Stimulation in Patients With Advanced Parkinson's Disease With Motor Complications and Relative or Absolute Contraindications for Subthalamic Stimulation

Boston Scientific Corporation

Insel Gruppe AG, University Hospital Bern

Neuralgia

Brain Neoplasms

Pain

Central Nervous System Neoplasms

Nervous System Neoplasms

Non-invasive brain intervention using MR-guided focused ultrasound

Non-invasive intervention with focused ultrasound (ExAblate 4000)

Javier - Fandino, MD

Ernst - Martin, MD

Focused Ultrasound Focused ultrasound is an attractive method for non-invasive thermal ablation of soft tissue tumors. Treatment begins by acquiring a series of MR images of the target organ. The physician then identifies a target volume in the MR images and delineates the treatment contours on the images. Therapy planning software calculates the parameters required to effectively treat the defined target volume. During the treatment an ultrasound transducer generates and focuses ultrasound energy to a focal point, called a sonication. The sonication raises the tissue temperature within a well-defined region to a degree, which causes thermal coagulation. MR images acquired during sonication provide a quantitative, real-time temperature map of the target area to confirm the location of the sonication and the size of the coagulated region. The sonication process is repeated at multiple adjacent points to cover the entire prescribed treatment volume.

Magnetic Resonance (MR) Guided Focused Ultrasound in the Treatment of Brain Tumors

MR-guided Ultrasound-Neurosurgery for the Treatment of Malignant Brain Tumors

Size of lesion in the tumor tissue for each sonication as a function of applied energy/temperature.

Number of Participants with Adverse Events as a Measure of Safety and Tolerability.

University Children's Hospital, Zurich

Heart and Blood Diseases

Blood and Lymph Conditions

Syndrome

Thrombosis

Breast Neoplasms

Lymphedema

Embolism

Embolism and Thrombosis

Vascular Diseases

Lymphatic Diseases

These users will come from the first moment of the diagnosis of the thrombus in our unit, to receive manual therapy by the physical therapist. They will receive 15 sessions of manual therapy by the physiotherapist, 5 days a week, each session being approximately 40 minutes long. The session will begin with pendulum exercises of the shoulder to warm up the joint and give proprioceptive stimulation to the joint capsule. The physiotherapist will perform passive stretches looking to put tension on the cord lymphatic, never exceeding grade 6 VAS pain. Mainly the shoulder will be worked affected, and if the cord reaches the crease of the elbow or thumb, the extension-supination of the elbow, and ulnar deviation of the wrist.

Scar massage will be done in the area where the lymphatic cord originates at the proximal level while maintaining the tolerable tension of the lymphatic cord (during the massage also pain grade 6 VAS will be exceeded).

These users will be instructed in hygienic-postural care and active auto-kinesitherapy assisted to perform daily for 30 minutes. The investigators will value following the instructions every 30 days

The physiotherapist performs passive kinesitherapy on the mastectomized patient with lymphatic thrombus, and scar massage when the arm maintains its greater range of mobility.

The patient will never present pain during the rehabilitation session above 5 in Pain Scale Analog Scale.

Manual Therapy, Physiotherapy, Kinesiology, Scar Massage

Kinesiotherapy, Physiotherapy, Health Education

Jesus G Physiotherapist, Physiothera

Jesús G González Rubiño, Graduate

Rocío Martín Valero, Physiothera

María Jesús Viñolo Gil, Physiothera

ABSTRACT

Breast cancer is the most common malignant tumor in women, with more than a million new cases annually. One of the most frequent surgical and post-actinic sequelae and well known is postmastectomy lymphedema. The axillary web syndrome is another sequel that limits the functionality of the patient and delays the protocol times of application of treatments cancer, and in many cases this sequela is misdiagnosed. This surgical sequelusually disappears spontaneously after the third month of appearance, but this implies a long period of discomfort and limitations for the user, at the same time that it may delay the application of Radiotherapy within the indicated protocol deadlines (due to the need for a body posture with abduction and flexion of the affected upper limb for its application and with the lymphatic thrombus is impossible to get).

With the present quasi-experimental study, the investigator intend to show that the application of Kinesitherapy and stretching from the beginning of the appearance of the cord, in a controlled and scheduled way by the physiotherapist, it is possible to reduce the time in which the lymphatic thrombus is present, and therefore, recover functionality, mobility, reduce pain and be able to apply the patients´ treatments within of the established deadlines. The investigator intend to apply this therapy in the intervention group and compare thrombus evolution times with the control group.

BACKGROUND AND CURRENT STATUS OF THE STUDY TOPIC

Breast Cancer is the most common tumor in women around the world, and is one of the leading causes of death among women in developed countries.

It is an important Public Health problem, since according to the World Health Organization more than a million new cases are diagnosed annually, becoming almost a quarter of malignant tumors in females. In the West, it has been shown that one in nine to twelve women will suffer from the disease in her lifetime.

Most cases occur in postmenopausal women, and the main age at diagnosis is around 60 years.

After the diagnosis of breast cancer, the patient undergoes surgical and / or cancer treatment. Chemotherapy, radiotherapy and hormonal therapy are some of the treatment alternatives, which currently are precisely adapted to the type of tumor seeking a better response and survival.

Postmastectomy lymphedema is one of the best-known postsurgical and post-actinic sequelae after breast cancer, with a prevalence of around 20% of mastectomized women.

The conservative treatment of this health problem is based on Decongestive Physical Therapy and Kinesitherapy. Pneumatic Multicompartmental Pressotherapy helps reduce the feeling of heaviness and stiffness of edema.

In addition to postmastectomy lymphedema, the patient undergoing surgery for breast cancer may present Axillary Web Syndrome (AWS) or superficial lymphatic thrombosis. As described by W.M. Yeung et al. In their systematic review, it can appear in the first eight weeks after the operation and usually resolves spontaneously within three months of its appearance.

The lymphatic thrombus is clinically manifested as a cord that frequently occurs in the armpit, although it can also appear along the upper limb, elbow crease even reaching the first finger. Regarding the diagnosis through imaging tests, nuclear magnetic resonance does not manage to clearly identify the axillary network syndrome, being ultrasound the most reliable method, due to the dynamism that can be applied to the patient's arm while the diagnostic test is being carried out.

The axillary network syndrome produces pain when abducting and flexing the shoulder, with the respective loss of functionality and limitation of mobility of the affected upper limb.

According to the American Cancer Society, radiation therapy is applied 3-8 weeks after the operation if chemotherapy is not required. If chemotherapy is used, it is applied 3-4 weeks after completion. It is usually applied 5 days a week from Monday to Friday.

The limitation of mobility often leads to a delay in the application of this useful tool in the oncological therapeutic arsenal to prevent recurrences. Hence, the need and importance of this study, where the investigator intend to demonstrate that the evolution times of the lymphatic thrombus can be reduced with assisted passive kinesitherapy and stretching.

At present, there are some publications that show possible alternatives of physiotherapy treatment for lymphatic thromb. Many are interventions with a very small sample (even on a caseby-case basis). Others are observational studies or even studies older than five years. There are some studies that combine manual lymphatic drainage (Vodder method) with physical therapy (strengthening, stretching, soft tissue work) with good results.

There is ambiguity in the relationship-association between the appearance of lymphatic thrombosis and lymphedema of the ipsilateral limb. Patients who have developed AWS are 44% more likely to develop postmastectomy lymphedema. There are other studies that do not find a relationship between the two.

The frequency of the AWS is not clear from the current posts. It depends on the type of surgical intervention, age, BMI, the appearance of the postoperative seroma, and even breast reconstruction. Thus being the frequency 30% of the operated patients.

After reviewing the relevant literature, it should be noted that there are very few studies and therefore little evidence on the treatment of AWS. It is not possible to prescript of a clear treatment in a clinical practice guide for this postsurgical sequela. Most publications highlight the importance and need for more research to determine the etiopathogenesis and useful treatment for this health issue.

OBJECTIVES GENERAL OBJECTIVES

I. Determine a preliminary exploration of the magnitude of the effect of a kinesitherapy and stretching intervention for the functional recovery of the upper limb, the recovery of the surgical scar and the improvement of the quality of life in women who have suffered from breast cancer. II. Create a scale to objectively classify the axillary thrombus (based on its clinical manifestations).

SPECIFIC OBJECTIVES for general objective I:

* Check the intervention of assisted passive kinesitherapy and stretching for the improvement of the range of joint mobility of the affected limb in the shortest possible time. - Analyze the reduction of pain and increase of the degree of functionality of the ipsilateral upper limb in patients with AWS after the intervention.
* Determine the impact of the physiotherapeutic intervention on the quality of life of a mastectomized woman with lymphatic thrombus.
* Analyse the physiotherapeutic intervention reduction of the time on the evolution of the Superficial Lymphatic Thrombus and the application of Radiotherapy within the terms established in the oncological protocols.

SPECIFIC OBJECTIVES for general objective II:

- Create a scale to objectively classify the axillary thrombus (based on its clinical manifestations).

METHODOLOGY TYPE OF STUDY

Quasi-experimental, prospective study.

STUDY POPULATION

The study sample is made up of patients undergoing surgery for Breast Cancer who attend the Lymphedema Unit of the A.G.S. Campo de Gibraltar Oeste presenting Lymphatic Thrombus after the operation, the recruitment period being from December 2021 to December 2023.

DESCRIPTION OF THE INTERVENTION

15 sessions of Assisted Passive Kinesitherapy are carried out by the physiotherapist. Five days a week, for three weeks. If it is previously referred, the treatment will be finished earlier (the patient must achieve the same ranges of motion and strength as the contralateral limb, together with the remission of pain).

The stretches applied during the sessions will be gentle and maintained, never exceeding a pain grade 5 VAS (moderate pain), once the tension of the cord is reached between 20-30 seconds. A special effort will be made to recover flexion and abduction of the shoulder, bringing the cord to a tolerable tension on the part of the patient.

Friction will be made on the axillary scar to dislodge underlying planes and the subcutaneous tissue of the muscle fascia.

The patient will be trained in active kinesitherapy to prevent lymphedema and activate lymphatic circulation. Also with hygienic-postural measures for the same purpose.

CONTROL GROUP

All the variables and data for each patients are recorded in their clinical history. Goniometric study will be performed of the affected upper limb (shoulder, elbow, wrist). Constant scale, Quick-Dash, the Visual Analog Pain Scale and the International Scale of Physical Activity will also be performed. This assessment will be carried out the patient arrives at our unit and on day 30, 60, 90.

These patients will be instructed in hygienic-postural care and active assisted autokinesitherapy to perform daily for 30 minutes. It will be assessed every 30 days.

These exercises are explained to the patient to be executed at home.

INTERVENTION GROUP

As well as the control group, all the variables and data for each patient will be collected in their medical history. Goniometric study of the affected upper limb will be performed too (shouderelbow-wrist). Constan scale, Quick- DASH, Visual Scale will also be completed together with Analogue of Pain and the International Scale of Physical Activity. This exploration will also take place during the first session and on the 30th, 60th and 90th day.

These users will arrive at the first diagnosis of the thrombus in our unit,in order to receive manual therapy by the physical therapist. (see therapy pictures).

They will receive 15 sessions of manual therapy the physiotherapist, 5 days a week ,each session being approximately 40 minutes long.

The session will begin with pendulum exercises of the shoulder to warm up the joint and give proprioceptive stimulation to the joint capsule.

The physiotherapist will perform passive stretches looking to tensioning the lymphatic cord, never exceeding grade 6 VAS pain chart. Mainly the affected shoulder will be treated and if the cord reaches the crease of the elbow or thumb, the extension (frase sin sentido general hay que volverla a escribir).

Scar massage will be done in the area where the lymphatic cord originates at the proximal level while maintaining the tolerable tension of the lymphatic cord (during the massage also pain grade 6VAS will be exceeded).

Patients with developed lymphedema will receive Decongestive Physical Therapy (PDT) on the treated limb once the 15 day treatment described for the study is finished. Therefore, PDT does not influence on obtained contaminated results. Those patients who do not suffer from lymphedema do not receive PDT.

The randomization of the sample is done through the Excel program, where the "randomization" function distributes the numbers from 1 to 46 (number of research members) in the control group or intervention group.

As patients with this health problem arrive, they are distributed in order of arrival in both groups as determined by randomization

Effects of a Manual Therapy Program to Reduce the Evolution Time of Axillary Web Syndrome

1. Publication in journals indexed in the Journal Citation Report (JCR), in the field of Oncology and Rehabilitation and Physical Medicine and Physiotherapy.
2. Dissemination of results in national and international Congresses of Oncology and Rehabilitation and Physical Medicine and Physiotherapy.
3. Dissemination to the public, press releases and explanatory brochures of the project.
4. Dissemination on the website of the A.G.S. Campo de Gibraltar West.

The investigators will use Goniometry of both shoulders. It is a continuous quantitative variable. Goniometer is the standard instrument for measuring the range of movement. The patients were asked to move thir arms in flexion, extension, abduction and external and internal rotation of the shoulder. It was considered that the maximum range of motion for the flexion and abduction was 180º, for extension it was 45º, 100º for internal rotation and 80º for external rotation. Finally, a single index was calculated as the percentage of global movement ().

The investigators will use the Barthel Scale.

The Barthel index or Barthel scale is an instrument used by social and health professionals for the functional assessment of a patient and to monitor their evolution. In the case of Social Workers, they value the independence or dependence of the person in each of the activities of daily living (ADL), obtaining as a result the level of performance of the person and carrying out a rehabilitative / compensatory intervention and / or maintenance according to the results obtained. Promoting and / or maintaining the independence of the person.

The scale measures the ability of a person to perform 10 activities of daily life, which are considered basic, in this way a quantitative estimate of their degree of independence is obtained. 100 points is the highest score and the best result in the patient's functionality. 0 points is the worst result and shows the worst functional status.

The investigators will use the DASH Scale.

The Disabilities of the Hand, Arm and Shoulder (DASH) questionnaire is a specific instrument for measuring the quality of life related to health problems to the upper limbs. It is validated in Spanish and it consists of 30 questions. The final score calculation is relatively complicated. In order to calculate the scores it is necessary to have answered at least 27 out of the 30 questions. The final scores is obtained by calculating the arithmetic means of the questions answered minus 1 times 25. The DASH questionnaire has excellent reproductibility and high sensitivity, being able to detect small changes. The scale ranges from 30 to 150 points. 30 points means good shoulder functionality and 150 non-functional shoulder.

It has two optional subsections where sports and work functionality can be assessed.

The investigators will use the Visual Analog Pain Scale.

According to the National Cancer Institue ( NIH), it is a tool used to help the professional assess the intensity of certain sensations and feelings, such as pain. The Visual Analog Scale for pain is composed of a straight line on which an extreme means no pain and the other extreme means the worst pain imaginable.

Extreme pain corresponds to 10 points. None pain corresponds to 0 points.

The patient marks a point on the line that matches the amount of pain they feel. Also known as VAS.

The investigators wil use the Constant Scale. Constant Scale: According to the Spanish Society for Shoulder and Elbow Surgery (SECHC), the Constant Scale assesses pain, functionality for daily life activities, joint mobility and shoulder strength. Also, it considers the laterality and the time it takes the patient. The score ranges from 0 points to 100 points, being 100 the optimal condition for the shoulder.

University of Malaga

Principal Investigator

Diseases and Abnormalities at or Before Birth

Rare Diseases

Sclerosis

Epilepsy

Tuberous Sclerosis

Hamartoma

Neoplasms, Multiple Primary

Neoplastic Syndromes, Hereditary

Congenital Abnormalities

Malformations of Cortical Development

Nervous System Malformations

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Genetic Diseases, Inborn

Tuberous Sclerosis Complex

Early Infantile Epileptic Encephalopathy 4

Ann Hallemans, PhD

Patricia Van de Walle, PT, PhD

Anna Jansen, MD, PhD

The aim of this pilot study is to explore whether the knowledge and experience gained during the T-GaiD project (Treatment of Gait Disorders in Dravet Syndrome - NCT03857451) can be transferred to other populations with similar problems, i.e. motor and gait problems as a result of a genetic disorder characterized by epilepsy and developmental delay. In this pilot study, 40 people with Tuberous Sclerosis Complex and 30 people with STXBP1 will be recruited via the Antwerp University Hospital and invited for a gait analysis in the M²OCEAN movement lab. The aim of the pilot study is to evaluate the feasibility of the 3D gait analysis protocol and to determine the sensitivity of the primary (summative measure of the severity of gait abnormalities) and the secondary (spatio-temporal and kinematic gait parameters) outcome measures.

Neurodevelopmental disorders are a group of rare disorders that usually have a genetic cause, each characterized by specific clinical features. Tuberous Sclerosis Complex (TSC or Bourneville's disease), for example, is characterized by the formation of benign tumors, which can develop in almost all organs and tissues. The symptoms vary greatly from person to person, also within one and the same family. Some patients show only limited skin abnormalities, other patients have more affected organs and sometimes become heavily dependent on help. The group of developmental and epileptic encephalopathies (DEE) are genetic neurological disorders that are characterized by epileptic seizures, which usually occur at a (very) young age, and a developmental delay that often leads to an intellectual disability. STXBP1 encephalopathy (STXBP1-E) is an example of an DEE where, in addition to epileptic seizures and developmental delay, motor disorders and gait abnormalities are also frequently seen.

To date, very little is known about motor development in children with TSC and DEE such as STXBP1-RD. Prospective research in the EPISTOP cohort showed that motor development is often delayed in the first years of life, especially in children who also show characteristics of. In clinical practice, we observe progressively increasing gait problems in a number of children that can lead to loss of autonomous steps at a young adult age. A recent study in adult patients with STXBP1-RD showed that about half of the patients were able to walk in adulthood and that those who could walk often had significant gait problems, which appear to be multifactorial in nature.

The ultimate goal of this project is to characterize gait patterns in children, adolescents and young adults with rare genetic disorders, in order to gain new insights into the pathomechanisms of motor and mobility problems. In the long run, these insights will be indispensable for providing an adequate, scientifically substantiated treatment to reduce and, if possible, prevent the gait disorders.

Gait in Rare Diseases

Identification of Gait Disorders in Children, Adolescents and Young Adults With Rare Genetic Diseases

body height will be measured in standing position using a ruler and expressed in centimeters

weight in kilograms will be measured using a calibrated scale

height (in centimeters) and weight (in kilograms) will be combined to determine the body mass index

leg length in centimeters will be measured from the anterior superior iliac spine to the medial malleolus, using a tape measure

Passive joint range of motion (in degrees) will be measured during clinical examination using a goniometer

Skeletal alignment (in degrees) will be measured during clinical examination using a goniometer. Skeletal malformations such as hyperlordosis, kyphosis, bow legs, pes valgus and pes planovalgus will be recorded.

Hamstrings length (popliteal angle in degrees) and iliopsoas length (Thomas test in degrees) will be measured during clinical examination using a goniometer

The Medical Research Council muscle scale is a 6-point scale with minimum score 0 = no muscle contraction and maximum score 5 = normal muscle power.

To obtain a summary index of overall gait pathology, the Gait Profile Score will be calculated based on nine relevant lower limb joint angular time profiles collected during 3D gait analysis. These are anterior pelvic tilt, pelvic list, pelvic rotation, hip flexion and extension, hip ad- and abduction, hip rotation, knee flexion and extension, ankle dorsi- and plantar flexion and the foot progression angle. The gait profile score provides the average root mean squared error of the joint angular time profile with respect to normal walking and is presented in degrees. Higher values indicate a larger deviations from normal gait.

The gait pattern is assessed by instrumented 3D gait analysis using the standardized Vicon Clinical Gait Model. Joint rotation angles of the major joints of the lower limbs will be described during walking.

Functional mobility will be assessed during parent interview using the Functional Mobility Scale (FMS). The FMS is a 6-point scale with maximum score of 6 being the most functional outcome (independent on all surfaces) and minimum score of 1 being the least functional outcome (uses wheelchair)

Mobility limitations during daily activities inside and outside of the house will be assessed during parent interview using the validated Dutch translation of the Mobility Questionnaire 28 (MobQuest28), Dutch version: MobiliteitsVragenlijst 28 (MoVra28). The MobQuest28/MoVra28 consists of 28 items with a 5-point rating scale (0 = without any difficulties to 4 = impossible without help). A total score (0-100) indicates the mobility limitations.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bilateral Pallidal Stimulation in Patients With Advanced Parkinson's Disease-LATESTIM	NCT02823158	Central Nervous... Basal Ganglia D... Movement Disord... Neurodegenerati... Parkinson Disea...	Deep brain stim... Best medical tr...	18 Years - 85 Years	Insel Gruppe AG, University Hospital Bern
Magnetic Resonance (MR) Guided Focused Ultrasound in the Treatment of Brain Tumors	NCT01698437	Malignant Brain...	Non-invasive in...	18 Years -	University Children's Hospital, Zurich
Magnetic Resonance (MR) Guided Focused Ultrasound in the Treatment of Brain Tumors	NCT01698437	Malignant Brain...	Non-invasive in...	18 Years -	University Children's Hospital, Zurich
Effects of a Manual Therapy Program to Reduce the Evolution Time of Axillary Web Syndrome	NCT05115799	Breast Cancer Mastectomy; Lym... Thrombi Thrombosis Shoulder Syndro... Movement Disord...	Manual Therapy,... Kinesiotherapy,...	18 Years -	University of Malaga
Gait in Rare Diseases	NCT05161494	Tuberous Sclero... STXBP1 Encephal...		6 Years - 25 Years	Universiteit Antwerpen
Bilateral Pallidal Stimulation in Patients With Advanced Parkinson's Disease-LATESTIM	NCT02823158	Central Nervous... Basal Ganglia D... Movement Disord... Neurodegenerati... Parkinson Disea...	Deep brain stim... Best medical tr...	18 Years - 85 Years	Insel Gruppe AG, University Hospital Bern

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