N/A
N=10
rTMS Therapy for Primary Orthostatic Tremor
Primary Orthostatic Tremor
Bottom Line
View on ClinicalTrials.gov: NCT02441985 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Change in Fullerton Advanced Balance (FAB) Scale Total Score After rTMS — 2.8; 0.9 change in score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Magstim RapidStim2 (Device); Sham Magstim RapidStim2 (Device); Fullerton Advanced Balance (FAB) Scale (Other); Timed "Up & Go" Test (TUG) test (Other); 10m walk test (Other); Tremor electrophysiology (Other); Cerebellar-brain Inhibition (CBI) (Other)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Fullerton Advanced Balance (FAB) Scale Total Score After rTMS |
2.8; 0.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Potential participants will be diagnosed with Primary orthostatic tremor (POT) and be recruited through IRB approved database maintained by the Movement Disorders Center
Exclusion Criteria
- Pregnancy
- Active seizure disorder
- Significant cognitive impairment
- Presence of a metallic body such as pacemaker, implants, prosthesis,artificial limb or joint, shunt, metal rods and hearing aid
Data sourced from ClinicalTrials.gov (NCT02441985). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.