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Non-invasive Brain Stimulation

TMS for Functional Movement Disorder

Phase 2

Recruiting

Led By Hyun Joo Cho, M.D.

Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility Criteria Checklist

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

Must have

Diagnosis of functional movement disorder made by a neurologist

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 2 and 6 months after itbs

Awards & highlights

Study Summary

This trial will test whether transcranial magnetic stimulation (TMS) can improve symptoms for people with functional movement disorders (FMD).

Who is the study for?

This trial is for adults aged 18-80 diagnosed with Functional Movement Disorder (FMD) by a neurologist. Participants must be willing to follow the study procedures, not have significant neurological disorders other than FMD, no current psychosis or active suicidal thoughts, and not be pregnant.Check my eligibility

What is being tested?

The trial tests if non-invasive brain stimulation using Theta Burst Stimulation (TMS) can improve symptoms of FMD. Participants are randomly assigned to receive either real TMS or sham (fake) stimulation over five daily sessions, followed by evaluations up to six months after treatment.See study design

What are the potential side effects?

While the document doesn't specify side effects, typical TMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases. The sham procedure should ideally have no side effects.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with a functional movement disorder by a neurologist.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 2 and 6 months after itbs

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 2 and 6 months after itbs

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 2 and 6 months after itbs for reporting.

Treatment Details

Study Objectives

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

Secondary outcome measures

CGI

S-FMDRS

SF-36

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment1 Intervention

Active TMS stimulation using an active TMS coil

Group II: ControlPlacebo Group1 Intervention

Sham TMS stimulation using a sham coil

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MagStim

2003

N/A

~30

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor

1,340 Previous Clinical Trials

649,309 Total Patients Enrolled

Hyun Joo Cho, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)

2 Previous Clinical Trials

312 Total Patients Enrolled

Media Library

Intermittent Theta Burst Stimulation (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05155059 — Phase 2

Functional Movement Disorder Research Study Groups: Control, Treatment

Functional Movement Disorder Clinical Trial 2023: Intermittent Theta Burst Stimulation Highlights & Side Effects. Trial Name: NCT05155059 — Phase 2

Intermittent Theta Burst Stimulation (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05155059 — Phase 2

Frequently Asked Questions

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

Has the Federal Drug Administration certified MagStim for public use?

"MagStim has been studied for safety in a Phase 2 trial, which is why our team at Power rated its risk level as a 2. However, no efficacy data exists yet on the drug's effects."

Answered by AI

Is this clinical trial open to participants under the age of 35?

"The age range for those who qualify to participate in this trial is 18-80 years. There are 251 trials available for minors and 641 studies suited toward seniors."

Answered by AI

Who is eligible to participate in this medical experiment?

"This medical trial is seeking individuals, aged 18 to 80 and currently diagnosed with functional movement disorder by a neurologist. Participants must also agree to all study protocols throughout the duration of the study and adhere to lifestyle considerations; they must have the cognitive capacity to understand procedures as well as sign an informed consent document. Fifty participants will be accepted in total."

Answered by AI

Is this trial actively recruiting participants?

"The data hosted on clinicaltrials.gov affirms that this trial is currently in the recruitment stage, with its first posting dated May 6th 2022 and most recent update occurring October 21st of the same year."

Answered by AI

What is the participant count for this research endeavor?

"Affirmative. Information from clinicaltrials.gov reveals that this medical study, first made available May 6th 2022, is actively enrolling patients. A total of 50 participants are required to be recruited across a single site."

Answered by AI

Recent research and studies

Brain SciencesJournal

Corticolimbic Modulation via Intermittent Theta Burst Stimulation as a Novel Treatment for Functional Movement Disorder: A Proof-of-concept Study

Spagnolo, Primavera A., Jacob Parker, Silvina Horovitz, and Mark Hallett. 2021. “Corticolimbic Modulation via Intermittent Theta Burst Stimulation as a Novel Treatment for Functional Movement Disorder: A Proof-of-concept Study”. Brain Sciences. MDPI AG. doi:10.3390/brainsci11060791.

clinicaltrials.govStudy

Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Functional Movement Disorders

2022. "Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Functional Movement Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05155059.