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N/A N=10 Randomized Triple-blind Treatment

rTMS Therapy for Primary Orthostatic Tremor

Primary Orthostatic Tremor

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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