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Transcranial Magnetic Stimulation for Parkinson's Disease

N/A

Recruiting

Led By Miriam Sklerov, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men and women between 50 and 90 years of age, without a diagnosis of severe dementia

Carry a diagnosis of idiopathic Parkinson's disease based on the United Kingdom Parkinson's Disease Society Brain Bank clinical diagnostic criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at least 30 minutes before each itbs treatment, and day 1 and day 4 after each itbs treatment

Awards & highlights

Study Summary

This trial is testing transcranial magnetic stimulation (TMS) as a potential treatment for Parkinson's disease related autonomic dysfunction and depression. TMS is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain. This study will test whether TMS can improve symptoms of Parkinson's disease.

Who is the study for?

This trial is for men and women aged 50-90 with Parkinson's disease, who've had symptoms for at least 3 years, can consent in English, and don't have severe dementia. Women must not be menstruating or must use contraception. Excluded are those with epilepsy, brain surgery history, severe tremor/dyskinesia affecting EEGs, conditions causing orthostatic hypotension (like heart failure), CNS diseases affecting EEG/TMS results, or metal implants.Check my eligibility

What is being tested?

The study tests if transcranial magnetic stimulation (TMS) can treat non-motor symptoms of Parkinson's like autonomic dysfunction and depression. Participants will receive TMS on three different brain areas in a randomized order: the medial prefrontal cortex (experimental), dorsolateral prefrontal cortex (alternative experimental), and primary sensory cortex (control).See study design

What are the potential side effects?

While the description doesn't specify side effects of TMS directly related to this trial, common ones include headache, scalp discomfort at the stimulation site, tingling or spasms of facial muscles.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 50 and 90 years old and do not have severe dementia.

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I have been diagnosed with Parkinson's disease.

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I can understand and consent to the study in English.

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I have had Parkinson's disease symptoms for 3 years or more.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at least 30 minutes before initial itbs, and 30 minutes after each itbs treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at least 30 minutes before initial itbs, and 30 minutes after each itbs treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and at least 30 minutes before initial itbs, and 30 minutes after each itbs treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in frontal midline theta EEG power after brain stimulation

Correlation between degree of orthostatic hypotension and EEG

Correlation between the Orthostatic Hypotension Questionnaire (OHQ) and EEG

+2 more

Other outcome measures

Depression symptom response to brain stimulation

OHQ response to brain stimulation

Response of orthostatic blood pressure changes to brain stimulation

+1 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: medial prefrontal cortex - dorsolateral prefrontal cortex - control siteExperimental Treatment1 Intervention

Participants first undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the control site.

Group II: medial prefrontal cortex - control site - dorsolateral prefrontal cortexExperimental Treatment1 Intervention

Participants first undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the control site. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex.

Group III: dorsolateral prefrontal cortex - medial prefrontal cortex - control siteExperimental Treatment1 Intervention

Participants first undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the control site.

Group IV: dorsolateral prefrontal cortex - control site - medial prefrontal cortexExperimental Treatment1 Intervention

Participants first undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the control site. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the medial prefrontal cortex.

Group V: control site - medial prefrontal cortex - dorsolateral prefrontal cortexExperimental Treatment1 Intervention

Participants first undergo transcranial magnetic stimulation to the control site. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the medial prefrontal cortex. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex.

Group VI: control site - dorsolateral prefrontal cortex - medial prefrontal cortexExperimental Treatment1 Intervention

Participants first undergo transcranial magnetic stimulation to the control site. After a 3 week washout period, participants then undergo transcranial magnetic stimulation to the dorsolateral prefrontal cortex. After a 3 week washout period, participants undergo transcranial magnetic stimulation to the medial prefrontal cortex.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

transcranial magnetic stimulation

2013

Completed Phase 2

~710

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,190,997 Total Patients Enrolled

Miriam Sklerov, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

1 Previous Clinical Trials

60 Total Patients Enrolled

Media Library

Transcranial Magnetic Stimulation (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05205772 — N/A

Parkinson's Disease Research Study Groups: control site - dorsolateral prefrontal cortex - medial prefrontal cortex, control site - medial prefrontal cortex - dorsolateral prefrontal cortex, medial prefrontal cortex - control site - dorsolateral prefrontal cortex, medial prefrontal cortex - dorsolateral prefrontal cortex - control site, dorsolateral prefrontal cortex - medial prefrontal cortex - control site, dorsolateral prefrontal cortex - control site - medial prefrontal cortex

Parkinson's Disease Clinical Trial 2023: Transcranial Magnetic Stimulation Highlights & Side Effects. Trial Name: NCT05205772 — N/A

Transcranial Magnetic Stimulation (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05205772 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant count for this research?

"Correct. Per information posted on clinicaltrials.gov, this medical study is actively looking for participants; it was initially published February 1st 2022 and the last update being on February 23rd 2022. 45 individuals are needed from one site to take part in the experiment."

Answered by AI

What criteria must be met for someone to qualify as a participant in the study?

"To qualify for participation in this experiment, individuals must have been diagnosed with a depressive disorder and be aged between 50 to 90 years-old. Currently 45 participants are sought after."

Answered by AI

Does the trial accept elderly people in their 75th year or older?

"The qualifications for this trial dictate that individuals between the ages of 50 and 90 are eligible. Separately, there are 207 studies suitable for minors and 1328 trials catered to seniors."

Answered by AI

Are researchers still enrolling volunteers for this experiment?

"Verifiable evidence on clinicaltrials.gov suggests that recruitment is ongoing for this trial, which was first announced February 1st 2022 and most recently updated on the 23rd of the same month."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Investigating Central Neurophysiologic Correlates of Non-Motor Symptoms of Parkinson's Disease

2022. "Investigating Central Neurophysiologic Correlates of Non-Motor Symptoms of Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05205772.

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