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NCT06982638 · ClinicalTrials.gov registry record · NA
Accelerated TMS for Freezing of Gait in Parkinson's Disease
A NA study of Parkinson's Disease (PD), sponsored by Medical University of South Carolina.
- Recruiting
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT06982638: Recruiting NA study of Parkinson's Disease (PD), sponsored by Medical University of South Carolina.
NCT06982638 is a NA study of Parkinson's Disease (PD) that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 12 participants, below the 54-participant average among 4 other Parkinson's Disease (PD) trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06982638, a NA study of Parkinson's Disease (PD), is actively recruiting participants, sponsored by Medical University of South Carolina.
- RECRUITING
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to learn whether a personalized brain stimulation method called repetitive transcranial magnetic stimulation (rTMS), combined with walking exercises, is a practical and tolerable approach to help people with Parkinson's disease who experience freezing of gait (FOG). FOG is a disabling symptom where people temporarily feel stuck and unable to start walking, even though they want to move. The main questions this study aims to answer are: Can people with Parkinson's disease and FOG tolerate this combined rTMS and walking training procedure? Can researchers successfully enroll and retain participants for this multi-visit intervention? Does the combination of rTMS and gait training show early signs of improving gait and reducing freezing episodes? This study does not include a comparison or placebo group. All participants will receive the same intervention. Participants will: Attend up to 15 study visits over about 16 weeks, with the option to combine visits to reduce burden. Complete brain imaging (MRI) before and after the intervention to guide and evaluate treatment. Receive a form of brain stimulation (rTMS) using a safe, non-invasive coil placed over a specific part of the brain called the supplementary motor area (SMA). The target is personalized using each person's MRI data. Participate in walking exercises that include cognitive tasks (dual-task gait training) after each set of brain stimulation sessions. Undergo assessments of walking ability, Parkinson's disease symptoms, and brain response to stimulation. Be videotaped during walking tasks to assess gait changes, while wearing small motion sensors on the body. Complete questionnaires about symptoms, safety, and tolerability. This study is being conducted at the Medical University of South Carolina (MUSC) and includes up to 15 adults between the ages of 50 and 80 who have been diagnosed with Parkinson's disease and experience FOG. Although rTMS is already FDA-cl
Primary Outcome
Participant-reported discomfort after each TMS session using a modified version of the Non-Invasive Brain Stimulation (NIBS) Tolerability Questionnaire, which rates six side effects (headache, pain, scalp irritation, facial twitching, fatigue, fear/anxiety) from 1 (Mild) to 10 (Severe).
Conditions Studied
Interventions
- DEVICE TMS+ Gait training
Study Locations (1)
South Carolina
- Medical University of South Carlina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-11-21 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What NCT06982638 shows while recruiting
NCT06982638 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 54-participant average among 4 other Parkinson's Disease (PD) trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Parkinson's Disease (PD) appearing as the primary indexed condition, and to 1 intervention - of which TMS+ Gait training is the first listed.
NCT06982638 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT06982638 about?
NCT06982638 is a clinical study titled "Accelerated TMS for Freezing of Gait in Parkinson's Disease". The goal of this clinical trial is to learn whether a personalized brain stimulation method called repetitive transcranial magnetic stimulation (rTMS), combined with walking exercises, is a practical and tolerable approach to help people with Parkinson's disease who experience freezing of gait (FOG)...
What is the current status of trial NCT06982638?
This trial is currently recruiting. It is a NA study. The enrollment target is 12 participants. The study started on 2024-11-21. Estimated completion is 2026-12-31.
What conditions does trial NCT06982638 study?
This clinical trial studies the following conditions: Parkinson's Disease (PD).
What interventions are being tested in trial NCT06982638?
The interventions under investigation include: TMS+ Gait training (DEVICE).
Who is sponsoring clinical trial NCT06982638?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06982638 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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