Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Ganglion Cysts

Parkinson Disease

Synovial Cyst

Cysts

Mucinoses

Connective Tissue Diseases

All patients will undergo both the SMA and the basal ganglia condition

Participants will be shown their brain activity measured in real-time using an MRI scanner. They can then use mental strategies, such as imagination to influence and regulate this activity.

Neurofeedback

David EJ Linden, Prof.

To investigate feasibility of basal-ganglia regions as fMRI-neurofeedback targets in Parkinson's patients and evaluate self-regulation success

This is a single-group proof of mechanism study of Parkinson's Disease (PD) patients receiving neurofeedback (NF) training using supplementary motor area (SMA) and basal ganglia as target areas. At the start of the screening session, consent will be taken. Subsequently, the screening assessment will be performed to determine inclusion and exclusion criteria. After inclusion in the study has been established, the NF sessions at the MRI scanner will be scheduled. The participants will be invited for up to three NF sessions. This will total up to a maximum of four visits, one for screening and up to three for the NF sessions. Due to the feasibility nature of the study, the optimal number of sessions for the patient cohort to learn the NF regulation is unknown. Therefore, flexibility has been introduced in the design to facilitate learning in case it is necessary. The NF training is modelled on the investigators' previous work.

Each NF session will consist of one anatomical scan, one localizer run, and four functional NF runs. The localizer run will be used to identify individualized brain activation patterns in the participants. Each NF run is a measurement sequence that will consist of ten blocks: five regulation blocks and five rest blocks. The participants will be asked to upregulate (increase) their brain activity, which will be displayed on a thermometer bar, during the regulation blocks. During the rest blocks, the participants will be asked to relax. The study will employ a crossover design with two conditions. In one condition the participants will receive feedback on the thermometer bar from the SMA region and in the second condition the participants will receive feedback from the basal ganglia region. Two of the NF runs will be with the SMA condition and two will be with the basal ganglia condition. Both runs in each condition will take place consecutively, i.e., either the first two runs will be SMA and the second two runs will be basal ganglia or vice versa. The sessions will be counter balanced.

At the last NF session, a post-training assessment will be conducted during which the participants will be debriefed about the study. NF is an individualized training method, and therefore, individual differences in learning success are expected during the study, which can lead to different expectations from the subjects. However, since this is an investigation of the feasibility of the approach, all forms of performance are useful datapoints and participants will be debriefed about their valuable contribution to make sure that no outcome is conceived as negative.

Brain Self-regulation for Parkinson's

A Feasibility Study of fMRI-neurofeedback in Parkinson's Disease

We will be investigating the ability of the basal ganglia to be used as a neurodeedback target for self-regulation in PD patients. To determine the ability of the basal ganglia to be recruited in the neurofeedback training, we will look at the T-contrast of all basal ganglia regulation blocks vs all baseline blocks in all the runs where basal ganglia was the target region.

To determine the performance of basal ganglia self-regulation, we will employ a T-contrast of all runs with the basal ganglia as the target region versus all the runs with the SMA as the target region. Additionally, we will assess whole-brain activation changes in the basal ganglia runs to determine specificity of the neurofeedback training. This can give us insight into which brain networks contribute mechanistically to the training and if any of the training performance can be attributed to other factors, such as physiological measures, as compared to neurofeedback self-regulation.

Maastricht University

Behaviors and Mental Disorders

Brain Neoplasms

Sleep Initiation and Maintenance Disorders

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

Sensory motor rhythm neurofeedback: The subjects will perform 60 minutes per week for 10 weeks, with a total training time of 600 minutes. The intervention in this trial lasts for 10 weeks (1 time/week), with the goal of improving sensory motor rhythm. Since this training uses visual and auditory feedback, if patients are assigned to this group, they will be ask to wear an EEG cap with 19 electrodes. They can take a relaxed sitting posture and choose animations (e.g., puzzles, mazes, and other feedback content), and then focus on computer screen animation for training, each training time is approximately 60 minutes.

Patient should maintain their usual activity and treatment. Research assistants will weekly contact them to confirm their compliance.

In this study, baseline brain waves will be recorded for 5 minutes before each treatment, and the average value of SMR waves was used as the basis for setting the treatment threshold for the week. During the treatment, the subjects are arranged to sit in front of a computer screen with a game or animation playing. The individual focuses on the games or animations on the screen. The software will analyze the brain wave signals from the brain and convert them into visual and auditory feedback on the computer screen. Clients can learn to control brain activity and give visual and auditory feedback when a set threshold is reached

sensorimotor rhythm neurofeedback training

Insomnia is the most common sleep disorder in patients with primary brain tumors. In the past, 21.5% to 59.2% of patients with primary brain tumors suffer from insomnia symptoms. In addition to hypnotics, nonpharmacological interventions for insomnia in patients with brain tumors are still lacking. When using hypnotics may cause daytime sleepiness, cognitive impairment, and increase the risk of cancer, seeking an effective intervention is of clinical importance. Sensorimotor rhythm neurofeedback therapy has been shown to improve insomnia in different populations. However, its effect on insomnia has not been explored in patients with brain tumors. We, therefore, aim to investigate the feasibility and effect of sensorimotor rhythm neurofeedback in improving insomnia in patients with benign brain tumors after surgery and to examine the correlation between the degree of insomnia improvement and quality of life changes after receiving sensorimotor rhythm neurofeedback.

Brain tumors are mainly divided into primary and metastatic, and are further divided into benign and malignant according to the pathological type. Among them, meningioma and pituitary tumor are the top two most common primary benign brain tumors, accounting for 36.1% respectively. -54.5% and 10-15%, while the most malignant glioblastoma accounts for 45-49.1% of primary malignant brain tumors. Among them, glioblastomas are more common in men and meningiomas are more common in women.

Insomnia is the most common sleep disorder in patients with primary brain tumors. Insomnia refers to difficulty falling asleep, staying awake and unable to fall asleep while sleeping, frequently waking up during sleep period or shortening sleep time, resulting in still feeling tired after getting up and affecting daily life functions. In the past, in terms of the prevalence of insomnia, primary brain 21.5%\~59.2% of patients with tumor had insomnia symptoms, and if subdivided into benign, 46.8% of patients with primary benign brain tumor.

According to the results of the study, patients with primary brain tumors still have widespread and persistent insomnia problems after treatment, and even up to one year after surgery, there are still studies showing insomnia problems. Savard et al (2011) reported that insomnia is also a cancer A common and persistent problem among patients, the attack rate of insomnia generally decreased over time, but remained prevalent (36%) even at the end of 18 months. However, in real life, although insomnia has a high attack rate and a high burden on the family, and even affects the overall quality of life of patients, it is often not valued and treated.

Neurofeedback (NFB), also known as brain wave training, is a method to help subjects consciously control their brain waves. In order to reflect the state of brain activity, the software analyzes the measured brain waves and provides feedback signals to teach individuals to self-regulate brain waves. After repeated training, the target brain waves can be generated. When the threshold is reached, it will give visual and auditory feedback. Neurofeedback has been used clinically in many diseases and healthy individuals that cannot be effectively treated with drugs, such as insomnia, ADHD, epilepsy, fibromyalgia, depression, anxiety, pain, learning and memory, etc. For insomnia, the use of neurofeedback therapy can help people who usually take an hour or so to fall asleep fall asleep faster.

According to Lambert-Beaudet et al. (2021) reviewing the latest research on the use of neurofeedback in the treatment of insomnia, the enhancement of sensorimotor rhythm neurofeedback to improve insomnia was the most included and confirmed to improve insomnia. And multiple studies have confirmed that sensorimotor rhythm neurofeedback enhancement training can lead to increased sleep spindle density, decreased sleep onset latency, increased total sleep time, and decreased wake-up after falling asleep. Therefore, sensorimotor rhythm neurofeedback enhancement training can be an effective method for non-drug intervention in the treatment of insomnia. Given that the effects of sensorimotor rhythm neurofeedback training on insomnia have not been studied in patients with benign brain tumors after surgery, further studies in this group are warranted.

Effects of SMR Neurofeedback on Insomnia in Patients With Benign Brain Tumors

Effects of Sensorimotor Rhythm Neurofeedback on Insomnia in Patients With Benign Brain Tumors Underwent Surgery

The ISI consists of seven items, and each item can be rated from 0 to 4, resulting in total score ranging from 0 to 28, with higher scores indicating greater insomnia severity. A cutoff score of \> 7 is used to diagnose subthreshold insomnia.

Sleep onset latency(SOL) is the time of duration from lying on bed to fall asleep. SOL shorter than 30 minutes is one of criteria of good sleep condition.

Wake after sleep onset(WASO) is the total time of wakefulness after sleep onset. WASO less than 30 minutes is one of criteria of good sleep condition.

Total sleep time(TST) is the total time of falling asleep. TST will be used to calculate sleep efficiency(SE).

Sleep efficiency(SE) is the percentage of total sleep time to time in bed. A good sleep condition should meet the criteria of SE greater than 85%.

The M.D. Anderson Syndrome Inventory-Taiwan Form (MDASI-Taiwan Form) is mainly used to assess the severity of various cancer symptoms in cancer patients due to cancer disease itself and various cancer treatments. The item, divided into two parts, the first part is the severity of cancer symptoms (symptom intensity): 0 points means no symptoms, 10 points means the most severe degree you can imagine, 1-3 points are mild, 4-6 points are mild Moderate, a score of 7 or more is severe; Part II: Severity of cancer symptoms that interfere with the functioning of life activities (life interference intensity): 0 means no interference, 10 means complete interference, and 1-3 means mild , 4 - 6 as moderate, 7 or more as severe.

Depression will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 21 questions to evaluate the state of depression, anxiety, and stress. 7 of the questions are used to measure the severity of depression. The total score should be multiplied by 2 range from 0-42, if score\>9 is associated with depression. The higher score means more severe depression

Anxiety will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 21 questions to evaluate the state of depression, anxiety, and stress. 7 of the questions are used to measure the severity of anxiety. The total score should be multiplied by 2 range from 0-42, if score\>7 is associated with anxiety. The higher score means more severe anxiety.

Stress will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 21 questions to evaluate the state of depression, anxiety, and stress. 7 of the questions are used to measure the severity of stress. The total score should be multiplied by 2 range from 0-42, if score\>14 is associated with anxiety. The higher score means more severe stress

Taipei Medical University

Associate Professor

Peripheral Nervous System Diseases

Neuromuscular Diseases

Analgesics

Psychotropic Drugs

Vasoconstrictor Agents

Cardiotonic Agents

Duloxetine Hydrochloride

Norepinephrine

Serotonin

Serotonin and Noradrenaline Reuptake Inhibitors

Neurotransmitter Agents

Antidepressive Agents

Dopamine

Dopamine Agents

Patients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks. Patients also receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.

Patients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks.

Patients receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.

Duloxetine

Quality-of-Life Assessment

Questionnaire Administration

Sarah Prinsloo

HILARY Y. MA

This phase II trial investigates how well duloxetine and neurofeedback training work in treating patients with chemotherapy induced peripheral neuropathy. Duloxetine is a type of serotonin and norepinephrine reuptake inhibitor that increases the amount of certain chemicals in the brain that help relieve depression and peripheral neuropathy. Neurofeedback training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity and may help teach patients with peripheral neuropathy (nerve damage) how to change their own brain waves to lower their feelings of neuropathy and help improve their overall quality of life. Giving duloxetine and neurofeedback training may work better in treating peripheral neuropathy caused by chemotherapy compared to duloxetine or neurofeedback training alone.

PRIMARY OBJECTIVE:

I. Determine if the combination of duloxetine (DL) and neurofeedback (NFB) is superior to DL or NFB alone in treating chemotherapy induced peripheral neuropathy (CIPN).

SECONDARY OBJECTIVES:

I. Determine the optimal number of neurofeedback sessions needed to result in long-term relief of CIPN in a large cohort of cancer survivors and across socioeconomic groups.

II. Examine baseline brain signatures as a predictor of response to neurofeedback (NFB) and to duloxetine and determine who will require more sessions of NFB to achieve relief of symptoms.

III. Examine if the combination of DL + NFB (than those getting DL or NFB alone) or a larger number of NFB sessions results in better improvements in cancer-related symptoms, physical functioning, and quality of life (QOL).

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP I: Patients receive neurofeedback training over 1 hour each 3-5 times weekly for up to 5 weeks. Patients also receive duloxetine orally (PO) once daily (QD) for 5 weeks in the absence of unacceptable toxicity.

GROUP II: Patients receive neurofeedback training session over 1 hour 3-5 times weekly for up to 5 weeks.

GROUP III: Patients receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.

After completion of study, patients are followed up at 6 and 12 months.

Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy

Optimizing Neurofeedback to Treat Chemotherapy Induced Peripheral Neuropathy

The primary analysis will be a linear model comparing the mean difference in the change of the unpleasantness subscale of the (PQAS)Pain Quality Assessment Scale from baseline to the end of treatment (5 weeks) between the combination arm, the duloxetine (DL), and the neurofeedback (NFB) arm while adjusting for the stratification factor. Pain Quality Assessment Scale (0-10) 0-No pain-10 Most Intense Pain Imaginable.

Will use analysis of covariance (ANCOVA) to evaluate whether chemotherapy induced peripheral neuropathy (CIPN) differs across the three subgroups with 0, 10 or 15 additional sessions of NFB, among the participants from the NFB + DL group who report at least 1-point clinical improvement in CIPN at week 5. The analysis will adjust for the baseline outcome (at week 5), time with CIPN symptoms (minimization factor), and other covariates such as age, sex, cancer stage, time since diagnosis, and cancer type, as appropriate. Pain Quality Assessment Scale (0-10) 0-No pain-10 Most Intense Pain Imaginable.

Will perform ANCOVA with the change of the unpleasantness subscale from baseline to week 5 (i.e., end of the first 15 sessions of NFB) as the outcome, intervention (NFB, DL or combo), the brain signature (one at a time) and its interaction with intervention as the independent variables of interest. Pain Quality Assessment Scale (0-10) 0-No pain-10 Most Intense Pain Imaginable.

Linear mixed model (LMM) analyses will be performed using data measured at end of treatment, months 6 and 12 only on patients who report clinical improvement at week 5.

ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on cancer-related symptoms.

ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on physical functioning.

ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on quality of life.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Carcinoma

Headache

Pain

Head and Neck Neoplasms

Analgesics, Opioid

Patients participate in CHAT counseling intervention over 45-60 minutes twice a month for up to 12 weeks.

Patients undergo NFB intervention over 20-30 minutes twice a week for up to 10 weeks.

Patients receive 2-3 standard of care sessions per month over 45-60 minutes for up to 12 weeks.

Best Practice

Participate in CHAT counseling intervention

Counseling

Electroencephalography

Sriram Yennu

This phase II trial compares different pain management interventions (standard of care \[SOC\], neurofeedback \[NFB\] training, and compassionate high alert team \[CHAT\]) in patients diagnosed with head and neck cancer who are at risk of developing non-medical opioid use (NMOU). The current standard treatment includes regular clinic visits and supportive care and counseling (including topics like patient-doctor communication, cancer care goals, financial issues counseling, and other topics). NFB training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity. The goal of NFB is to help teach patients with pain how to change their own brain waves to lower their feelings of pain and help improve their quality of life. CHAT is a supportive care intervention that includes symptom and pain management, counseling (about pain, symptoms, opioid use and safety, stress, and quality of life), and support for patients and their family members. NFB and CHAT may help to manage pain and lower patient use of opioids.

PRIMARY OBJECTIVE:

I. To test the hypothesis that this study will be feasible, as defined by adequate rates of adherence in the CHAT and NFB groups.

SECONDARY OBJECTIVES:

I. To examine the frequency of NMOU behaviors at the end of 3 months after CHAT, NFB, and SOC.

II. Examine the pain severity (area under the curve \[AUC\]), daily opioid use AUC of the cumulative morphine equivalent daily dose (MEDD), and mood (Hospital Anxiety and Depression Scale, HADS) for each of the treatment arms (CHAT, NFB, or SOC) in head and neck cancer (HNC) patients receiving radiation therapy at the end of 3 months.

EXPLORATORY OBJECTIVE:

I. To examine the cortical and subcortical regions of the brain associated with pain and our interventions (CHAT, NFB, and SOC) and the extent to which changes in electroencephalogram (EEG) patterns mediate the effects of the intervention.

OUTLINE: Patients are randomized into 1 of 3 arms.

ARM I: Patients participate in CHAT counseling intervention over 45-60 minutes twice a month for up to 12 weeks.

ARM II: Patients undergo NFB intervention over 20-30 minutes twice a week for up to 10 weeks.

ARM III: Patients receive 2-3 standard of care sessions per month over 45-60 minutes for up to 12 weeks.

Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients

Opioid-Sparing Interdisciplinary Interventions Addressing Pain in Head and Neck Cancer Patients

Composite NMOU score is calculated by summing the number of times each behavior suggestive of NMOU is recorded.

Rare Diseases

Brain Tumor, Childhood

Children in this group receive 30 sessions of neurofeedback

The children in this group receive 30 sessions of placebo feedback, based on muscular tension.

The siblings will be tested 1 time, they will function as a healthy control group.

30 sessions of neurofeedback will be given twice a week at the child's home. It will take about 15 weeks to complete the training.

Feedback based on a random signal generator and muscular tension instead of brain activity. 30 sessions at home, twice a week, total 15 weeks.

Placebo feedback

Introduction:

The aim of this study is to investigate the efficacy of neurofeedback (NFB) to improve attention, memory and processing speed in children treated for a Brain Tumour (BT). In the Netherlands every year approximately 100 children are diagnosed with a BT. Nowadays over 65% of these children have a 5-year survival. Treatment for a BT consists of neurosurgery and / or local or craniospinal radiation and / or adjuvant chemotherapy. Neurotoxicity caused by radiotherapy and / or chemotherapy (especially methotrexate) is a major cause of neurocognitive decline in Childhood Brain Tumour Survivors (CBTS).

Approach:

Studies have shown that NFB has the capacity to improve the brain systems mediating selective attention and response inhibition in children with Attention Deficit/Hyperactive Disorder (ADHD). The effectiveness is reported as comparable to methylphenidate (Ritalin) without side effects of medication. CBTS exhibit symptoms comparable to those of children with ADHD and positive response to methylphenidate has been found in CBTS. However, NFB has not been used as an intervention in CBTS yet. The effectiveness of NFB in children treated for a BT will be investigated in a randomized controlled trial. The intervention group of 30 patients will receive approximately 30 sessions of NFB; the control group will receive 30 session of placebo neurofeedback. Neuropsychological tests will be used to evaluate pre- and post-NFB intervention as well as at a 6-month follow-up.

Relevance:

If NFB proofs to be effective for CBTS this will be a great improvement for their (neuro-) psychological functioning and quality of life, without the disadvantage of the side effects of medication. The implementation of this intervention might increase cognitive and social functioning and thus facilitate integration of these children in society during childhood and school carrier as well as in adult life.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Brain Self-regulation for Parkinson's	NCT05627895	Basal-ganglia f...	Neurofeedback	18 Years -	Maastricht University
Effects of SMR Neurofeedback on Insomnia in Patients With Benign Brain Tumors	NCT05518942	Benign Brain Tu... Neurofeedback Insomnia	sensorimotor rh...	20 Years - 65 Years	Taipei Medical University
Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy	NCT04560673	Chemotherapy-In... Hematopoietic a... Malignant Solid...	Duloxetine Neurofeedback Quality-of-Life... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Effects of SMR Neurofeedback on Insomnia in Patients With Benign Brain Tumors	NCT05518942	Benign Brain Tu... Neurofeedback Insomnia	sensorimotor rh...	20 Years - 65 Years	Taipei Medical University
Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients	NCT05077072	Head and Neck C...	Best Practice Counseling Electroencephal... Neurofeedback Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients	NCT05077072	Head and Neck C...	Best Practice Counseling Electroencephal... Neurofeedback Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients	NCT05077072	Head and Neck C...	Best Practice Counseling Electroencephal... Neurofeedback Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Pediatric Research on Improving Speed, Memory and Attention	NCT00961922	Brain Tumors	Neurofeedback Placebo feedbac...	8 Years - 18 Years	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Brain Self-regulation for Parkinson's	NCT05627895	Basal-ganglia f...	Neurofeedback	18 Years -	Maastricht University
Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients	NCT05077072	Head and Neck C...	Best Practice Counseling Electroencephal... Neurofeedback Questionnaire A...	18 Years -	M.D. Anderson Cancer Center

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