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NCT02441985 · ClinicalTrials.gov registry record · NA
rTMS Therapy for Primary Orthostatic Tremor
A NA study, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT02441985: Completed NA study, sponsored by University of Florida.
NCT02441985 is a NA study that has completed, run by University of Florida. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02441985, a NA study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
Primary orthostatic tremor(POT) is a rare progressive functionally disabling tremor disorder. The characteristic features of POT are symptoms of unsteadiness in legs reported by patients when they are standing and improvement of symptoms upon walking and sitting. Due to the limited success of other treatment options there is a clear merit in continuing efforts to explore and investigate novel treatment modalities. Transcranial magnetic stimulation (TMS) is a well-established physiological tool to understand brain function. When repetitious TMS pulses are delivered to a specific target at predefined stimulation parameters, it is referred to as rTMS therapy.The investigators propose a novel approach to investigate the clinical and physiological effects of low frequency rTMS therapy in POT. The overarching hypothesis of this study is that low frequency rTMS therapy delivered to the cerebellum will modulate the cerebellar excitability and result in clinical improvements.In order to determine the physiological effects related to rTMS, the tremor physiology will also be recorded with surface electromyography (EMG). The investigator will also record the changes in cerebellum excitability in response to rTMS using cerebello-cortical inhibition (CBI), a well-established TMS parameter.
Primary Outcome
The Fullerton Advanced Balance (FAB) Scale is a clinical assessment of balance ability and fall risk. Participants complete 10 physical activity challenges while observed, and their performance is rated on a 0-4 scale, where a higher score a greater ability to balance. Each item is then summed to generate a Total Score, ranging from 0-40, where a higher total score indicates greater overall balance and lower likelihood of fall risk. The reported measure is the change in the FAB Total Score from
Interventions
- DEVICE Magstim RapidStim2
- DEVICE Sham Magstim RapidStim2
- OTHER Fullerton Advanced Balance (FAB) Scale
- OTHER Timed "Up & Go" Test (TUG) test
- OTHER 10m walk test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-08 |
| Est. Completion | 2019-01-08 |
| Phase | NA |
What the finished NCT02441985 record still lists
NCT02441985 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 5 interventions - of which Magstim RapidStim2 is the first listed.
NCT02441985 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02441985 about?
NCT02441985 is a clinical study titled "rTMS Therapy for Primary Orthostatic Tremor". Primary orthostatic tremor(POT) is a rare progressive functionally disabling tremor disorder. The characteristic features of POT are symptoms of unsteadiness in legs reported by patients when they are standing and improvement of symptoms upon walking and sitting. Due to the limited success of other ...
What is the current status of trial NCT02441985?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2015-08. Estimated completion is 2019-01-08.
What interventions are being tested in trial NCT02441985?
The interventions under investigation include: Magstim RapidStim2 (DEVICE), Sham Magstim RapidStim2 (DEVICE), Fullerton Advanced Balance (FAB) Scale (OTHER), Timed "Up & Go" Test (TUG) test (OTHER), 10m walk test (OTHER).
Who is sponsoring clinical trial NCT02441985?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02441985's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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