Nervous System Diseases

Symptoms and General Pathology

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Neuralgia

Cancer Pain

Chronic Pain

Pain

Neurologic Manifestations

Peripheral Nervous System Diseases

Neuromuscular Diseases

Quality of Life

Chronic Graft Versus Host Disease

Analgesics

All Drugs and Chemicals

Central Nervous System Depressants

Analgesics, Opioid

Subjects in this group are patients who opted for conservative medical management for their chronic pain that is cancer associated, including physical therapy, oral or transdermal medications and injections

Patients in this group are those that opted for targeted drug delivery along with conservative medical management of their cancer-associated pain

Intrathecal drug delivery systems (IDDs) deliver small doses of analgesics directly to the spinal cord.

Intrathecal Targeted Drug Delivery

Including physical therapy, oral or transdermal medications and injections

Conservative medical management

Mansoor M Aman, MD

Merve B Figueira, MS

Vishal M Patel, MD

This Registry study will prospectively evaluate the differences in treatment outcomes in terms of pain intensity, pain interference, concomitant medication use, health-related quality of life, opioid adverse effects, and healthcare utilization between targeted drug delivery and conservative medication management only groups.

This is a prospective, open-label, short term patient registry where up to 169 subjects with cancer associated pain will be enrolled. Subjects with cancer associated pain who are receiving conservative medical management (CMM) only and cancer patients receiving Intrathecal Drug Delivery system (IDDs) along with CMM will be followed for up to 3 months. Subjects will be evaluated monthly up to 3 months from the medical care initiation which is the implant day for the IDDs group and start of the new treatment plan for the CMM group. Subjects that decide to cross-over to the IDDs group in a future date, will still be followed for their progress.

Based on routine care, subjects will be seen at day of implant, 1 month post-implant, 2 months post-implant, and 3 months post-implant.

Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain

Intrathecal Targeted Drug Delivery for Cancer Associated Pain

Change from baseline to 2-Months post treatment plan implementation in average pain as measured through Numerical Rating Scale (0-10 where higher scores mean worse outcome)

Change from baseline to 2-Months post treatment plan implementation in pain interference as measured through Patient-Reported Outcomes Measurement Information System (PROMIS-29)

Average change from baseline to 2-Months in drug adverse levels as assessed through the Common Toxicity Criteria

Average change from baseline to 2-Months in oral opioid intake

Average change from baseline to 2-Months in patient well-being as measured through Functional Assessment of Cancer Therapy: General (FACT-G) (0-4 where higher scores mean worse outcome)

Average change from baseline to 2-Months in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome)

Change from baseline to 1-Month post treatment plan implementation in average pain as measured through Numerical Rating Scale (0-10 where higher scores mean worse outcome)

Change from baseline to 1-Month post treatment plan implementation in pain interference as measured through Patient-Reported Outcomes Measurement Information System (PROMIS-29)

Average change from baseline to 1-Month in drug adverse levels as assessed through the Common Toxicity Criteria

Average change from baseline to 1-Month in oral opioid intake

Average change from baseline to 1-Month in patient well-being as measured through Functional Assessment of Cancer Therapy: General (FACT-G) (0-4 where higher scores mean worse outcome)

Average change from baseline to 1-Month in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome)

Change from baseline to Month 3 post treatment plan implementation in average pain as measured through Numerical Rating Scale (0-10 where higher scores mean worse outcome)

Change from baseline to Month 3 post treatment plan implementation in pain interference as measured through Patient-Reported Outcomes Measurement Information System (PROMIS-29)

Average change from baseline to 3-Months in drug adverse levels as assessed through the Common Toxicity Criteria

Average change from baseline to 3-Months in oral opioid intake

Average change from baseline to 3-Months in healthcare utilization as assessed by number of emergency, inpatient, and outpatient visits due to pain

Average change from baseline to 3-Months in patient well-being as measured through Functional Assessment of Cancer Therapy: General (FACT-G) (0-4 where higher scores mean worse outcome)

Average change from baseline to 3-Months in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome)

Mansoor Aman, MD

Director, Interventional Pain Medicine- Oshkosh & Fond du Lac

Neoplasms

Skin and Connective Tissue Diseases

Migraine Disorders

Ganglion Cysts

Headache

Synovial Cyst

Cysts

Headache Disorders

Headache Disorders, Primary

Brain Diseases

Central Nervous System Diseases

Mucinoses

Connective Tissue Diseases

ATI Neurostimulator (NS-100) and Remote Controller (RC-200)

ATI Neurostimulation System

Rigmor Jensen, MD, PhD

The purpose of the clinical study is to evaluate the use of an implanted sphenopalatine ganglion (SPG) neurostimulator for the treatment of migraine headache pain, migraine headache symptoms and migraine frequency in high disability migraineurs.

Pathway M-1: Sphenopalatine Ganglion Stimulation for the AcuteTreatment of High Disability Migraine Headache

Migraine Free Day is any calendar day that:

1. Has less than 4 hours of moderate or severe pain meeting criteria C and D for migraine ICHD-II 1.1 AND
2. No Acute Headache or Migraine Pain Medication is used AND
3. No SPG stimulation is applied for headache pain of any intensity

Headache Free Day is any calendar day that:

1. Has less than 4 hours of moderate or severe pain AND
2. No Acute Headache or Migraine Pain Medication is used AND
3. No SPG stimulation is applied for headache pain of any intensity

Occurrence rate of death, any surgery or hospitalization due to deterioration in subject health, or other Major Device-related Adverse Events

Number of Migraine Pain Days during the Experimental Period, compared between the Treatment and Control arms.

Migraine Pain Day is any calendar day that:

1. Has less than 4 hours of moderate or severe pain meeting criteria C and D for migraine ICHD-II 1.1 AND
2. No Acute Headache or Migraine Pain Medication (pharmacologic medications, not including SPG stimulation, used to treat acute headache pain).

   AND
3. No SPG stimulation is applied for headache pain of any intensity

Autonomic Technologies, Inc.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Erectile Dysfunction

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Acute placement of electrodes and electrostimulation of the pelvic plexus nerves during open radical prostatectomy.

Acute placement of electrodes on the pelvic plexus to apply electrostimulation during open radical prostatectomy.

Nerve Stimulation

Spyridon Skoufias, MD

Ioannis Adamakis, MD

Constantinos A. Constantinides, MD

The purpose of this study is to evaluate the feasibility of electrical stimulation of nerves responsible for erectile function to evoke penile erection after surgery to remove the prostate (prostatectomy).

Prostate cancer is the main cancer in men. However, the survival rate for clinically localized prostate cancer is prominent mainly due to radical prostatectomy (RP), the gold standard treatment for non-metastatic cancers. Unfortunately, despite providing optimal cancer control, RP often lead to neuropraxia and persistent erectile dysfunction in approximately 80% of men 1 year after prostatectomy. Various erectile rehabilitation strategies have not been able to prove a beneficial action yet. However, electrical stimulation has been demonstrated to favour neuroregeneration and the functional recovery of neuromuscular systems and has been shown to induce and maintain penile erection in animals and humans. Therefore, electrical stimulation of the pelvic plexus nerves during radical prostatectomy is being investigated for its potential development into a treatment aimed at improving recovery of erectile function after prostatectomy.

The primary objective of this study is to explore the feasibility of using a neurostimulation device post radical prostatectomy as a method for neurogenic erectile dysfunction treatment. During standard open radical prostatectomy, the pelvic plexus nerves will be electrically stimulated intraoperatively and the modification of penile circumference will be recorded.

The secondary objective is to assess proper placement of the stimulation electrodes and stimulation parameters needed to achieve maximal change in penile circumference.

Intra-operative Neuromodulation of the Pelvic Plexus

Change in penile circumference \[mm\] in response to electrical stimulation of the pelvic plexus nerves measured by a penile plethysmograph.

The anatomic location of the stimulation site on the pelvic floor (determined by the surgeon).

Amplitude in volts of the electrical stimulation pulses to induce penile response.

Laikο General Hospital, Athens

MD, Principal investigator

Cognitive Dysfunction

Cognition Disorders

Neurocognitive Disorders

Patients will participate in the prospective longitudinal research protocol over a period of 1.5 months.

Treatment will include 8 visits of either accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS) or iTBS sham stimulation. Patients will be informed that iTBS sham stimulations will be part of the protocol (but will be blind to when treatment/sham will be administered).

Accelerated iTBS will be used to stimulate the regions of interest of mPFC and L-DLPFC nodes in cancer survivors or patients.

Accelerated iTBS will be administered in a single half-day period to allow for a 50minutes interval between any two treatments to minimize interference effects between treatments. Thus, there will be \~10 minute sessions of stimulation x 2 applications per node x 2 nodes (L-DLPFC, mPFC) = 40 total minutes of daily stimulation - each session delivers 1800 pulses in a 5 Hz triplet burst frequency, 2 second trains with intertrain interval of 8 seconds; triplets occur with 50 Hz frequency, as per standard iTBS protocols for depression treatment. The treatment will be offered for five consecutive days.

Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS)

Sneha Phadke, DO

This project is aimed at the discovery of neuro-modulation techniques that may alleviate chemotherapy induced cognitive deficits (CICD), especially in executive (higher-order) cognitive function (EF).

The specific aim for this study is to use magnetic resonance spectroscopy (MRS), self-report, and neuropsychological testing to identify changes in brain metabolite concentrations/ratios and changes in EF deficits associated with chemotherapy, before and after accelerated theta-burst transcranial stimulation (iTBS). The secondary aim is to assess for any association of changes in executive function with brain metabolite concentrations.

Accelerated Neuromodulation to Alleviate Cognitive Deficits Due to Cancer Therapy

Repetitive Intermittent Accelerated Theta-burst Transcranial Stimulation(iTBS) as a Potential Intervention for Chemotherapy Induced Cognitive Deficits (CICD)- a Pilot Clinical Trial to Explore Feasibility and Efficacy

Executive cognitive function will be quantified using technician administered Color Word Interference Test, Category Fluency, Tower of Hanoi, Card Sort and Strategy Application Task (Shallice \&Burgess) tests, and the self-report Functional Assessment of Cancer Therapy - Cognitive Scale (FACT-COG) (Dyk et al.). Executive Function (EF) is measured by utilizing standardized test scores adapted from the Delis-Kaplan Executive Function Scales (D-KEFS battery) (Homack et al.). FACT-COG, Category Fluency and Strategy Application Task use raw scores. All EF measures used in this battery form a part of a normative database created and maintained by the principle investigator of this study. An overall score of EF is computed by averaging the Z scores of each test. Higher score on each test represents better performance.

Proton Magnetic Resonance Spectroscopy will be used to quantify brain metabolite concentrations in parts per million. Brain metabolites under evaluation include: glutamine, glutamate, N-acetyl aspartate, choline, and creatine.

American Cancer Society-Holden Comprehensive Cancer Society

Fraternal Order of Eagles (Iowa)

Sneha Phadke

Clinical Associate Professor

Genital Neoplasms, Female

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

pelvic floor rehabilitation program with neuromodulation

Eun Joo Yang, MD.PhD

Eun Joo Yang, MD. PhD

Eun Joo Yang, MD, PhD

As cancer treatment improves, the cancer survivor's quality of life and level of function have gained increasing importance. Pelvic floor function is directly affected by gynecological cancer and treatment, and pelvic floor dysfunction (PFD) can severely affect a patient's life. PFD negatively affects health-related quality of life (HRQOL). Evaluation of PFD provides information about the disease burden and treatment-related effects directly from the patient's perspective and informs clinical decision-making. The pelvic floor musculature and sacral nerves are not easily accessible, and it is difficult to test them. Several functional assessments have been used to evaluate pelvic floor dysfunction; however, reports on methodology are sparse, and consensus on their use is lacking. Research on functional outcomes is highly complex and, consequently, must be addressed in a comprehensive framework.

Patients with cervical or colorectal cancer who underwent surgery or radiotherapy are recruited for the study.

* PFM strength is measured using a perineometer (BioCon-200,McubeTechnologyCompany,Seoul,Korea). Vaginal pressure is measured using a vaginal silicon pressure sensor (cmH2O; sensitivity0.06kPa,sensitivity 5mV, threshold1.5V).
* The motor evoked potentials (MEPs) from the pelvic floor are obtained by sacral and transcranial magnetic stimulation using a Magstim 200 stimulator (Magstim Co., Whitland, Wales, UK). Patients are instructed to lie in the left lateral decubitus position,intra-anal sponge electrode (Dantec,Skovlund, Denmark)was lubricated and gently inserted into the anal canal.
* Monophasic single pulses of magnetic stimuli were delivered to the vertex corresponding to the primary motor center in the precentral gyrus using a double-cone coil(9902-00,Magstim). A figure-eight coil(9762-00,Magstim)was used to stimulate the dorsolateral area of the sacrum corresponding to the exit of the sacral cortical facilitation
* We measured the latency, amplitude, and excitability threshold(ET) of MEPs detected in pelvic floor muscles with and without facilitation. The excitability threshold at rest(RET) is defined as the lowest intensity that produced MEP responses of 100μV For optimal facilitation, we measure the latency of the MEPs with minimal contraction (10% of MVC) with RET intensity and amplitude with a moderate contraction
* Patient-reported HRQOL Quality of life General and condition-specific aspects of HRQOL were assessed using the EORTC QLQ-C30 questionnaires.

Pelvic Floor Rehabilitation for Gynecological Cancer Patients

Neuromodulation System for Pelvic Floor Dysfunction Based on the Myo-neurophysiological Assessment for Gynecological Cancer Patients

We measure the amplitude (uV) of motor evoked potential (MEP) evoked by magnetic stimulation on the sacral plexus at the baseline and 1wk after intervention. Then we compare the change of the amplitude (1 wk after intervention-baseline)between two groups.

We measure the pelvic floor muscle strength using perometer (mmHg)at baseline and 1 wk after intervention then compare the change of pelvic floor muscle strength(1wk after intervention-baseline) between two groups.

We measure the latency (ms) of MEP evoked by magnetic stimulation on the sacral plexus and compare the change of latency (1wk after intervention-baseline)between two groups

We evaluate the functional score and symptom scale with EORTC QLQ-C30, EORTC QLQ-CX24 questionnaires and compare the change between two groups.

We evaluated the bladder, bowel, sexual functional scores with the interviewer-administered pelvic floor questionnaire at baseline and 1wk after intervention then compare the change of the scores between two groups

We measure the Hiatal dimension (mm) and levator plate angle (º) on maximal pelvic floor muscle contraction using ultrasound with curved transducer (3.5-6 MHz)at baseline and 1 wk after intervention and compare the change between two groups

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain	NCT05674240	Cancer Pain Chronic Pain Cancer Associat... Neuropathic Pai...	Intrathecal Tar... Conservative me...	21 Years -	Aurora Health Care
Pathway M-1: Sphenopalatine Ganglion Stimulation for the AcuteTreatment of High Disability Migraine Headache	NCT01540799	High Frequency,...	ATI Neurostimul...	18 Years -	Autonomic Technologies, Inc.
Intra-operative Neuromodulation of the Pelvic Plexus	NCT03425240	Erectile Dysfun... Prostate Cancer	Nerve Stimulati...	40 Years - 75 Years	Laikο General Hospital, Athens
Accelerated Neuromodulation to Alleviate Cognitive Deficits Due to Cancer Therapy	NCT04966520	Cancer	Accelerated rep...	18 Years - 99 Years	University of Iowa
Pelvic Floor Rehabilitation for Gynecological Cancer Patients	NCT01871688	Malignant Femal...	pelvic floor re...	18 Years -	Seoul National University Bundang Hospital
Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain	NCT05674240	Cancer Pain Chronic Pain Cancer Associat... Neuropathic Pai...	Intrathecal Tar... Conservative me...	21 Years -	Aurora Health Care
Intra-operative Neuromodulation of the Pelvic Plexus	NCT03425240	Erectile Dysfun... Prostate Cancer	Nerve Stimulati...	40 Years - 75 Years	Laikο General Hospital, Athens
Pathway M-1: Sphenopalatine Ganglion Stimulation for the AcuteTreatment of High Disability Migraine Headache	NCT01540799	High Frequency,...	ATI Neurostimul...	18 Years -	Autonomic Technologies, Inc.
Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain	NCT05674240	Cancer Pain Chronic Pain Cancer Associat... Neuropathic Pai...	Intrathecal Tar... Conservative me...	21 Years -	Aurora Health Care

Spots Global Cancer Trial Database for neuromodulation