CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Magstim RapidStim2 +6 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02441985
NCT02441985N/ACompleted

rTMS Therapy for Primary Orthostatic Tremor: A Novel Treatment Approach

University of Florida·interventional·Posted May 12, 2015·Updated Apr 2, 2025

In Brief

A clinical study evaluating Magstim RapidStim2, Sham Magstim RapidStim2, and 5 other interventions for Primary Orthostatic Tremor. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 12, 2015
Enrollment StartAug 1, 2015
Primary CompletionJan 8, 2019
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 11.1 years ago

Interventions

Magstim RapidStim2device

Application of repetitious transcranial magnetic stimulation (TMS) pulses using Magstim RapidStim2 to a specific brain target at predefined stimulation parameters.

Sham Magstim RapidStim2device

Same procedure as real rTMS without stimulating the cerebral cortex.

Fullerton Advanced Balance (FAB) Scaleother

All participants will receive a clinical assessment of balance ability and fall risk.

Timed "Up & Go" Test (TUG) testother

All participants will receive a clinical assessment of basic mobility skills by using the TUG test.

10m walk testother

All participants will receive a clinical assessment of walking speed by using the walk test.

Tremor electrophysiologyother

All participant tremors will by analyzed using an EMG system

Cerebellar-brain Inhibition (CBI)other

All participants will have a measure of the cerebellar-brain inhibition (CBI) which will be conducted by using a TMS device determining the ability of the coil to activate the cerebellum.