rTMS Therapy for Primary Orthostatic Tremor

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.

Conditions

• Primary Orthostatic Tremor

Interventions

DEVICE

Magstim RapidStim2

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

DEVICE

Sham Magstim RapidStim2

Same procedure as real rTMS without stimulating the cerebral cortex.

OTHER

Fullerton Advanced Balance (FAB) Scale

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

OTHER

Timed "Up & Go" Test (TUG) test

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

OTHER

10m walk test

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

OTHER

Tremor electrophysiology

All participant tremors will by analyzed using an EMG system

OTHER

Cerebellar-brain Inhibition (CBI)

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.

Sponsors & Collaborators

• National Organization for Rare Disorders

  collaborator OTHER

• Neuronetics

  collaborator OTHER

• University of Florida

  lead OTHER

Principal Investigators

• Aparna Wagle-Shukla, M.D. · Center for Movement Disorders and Neurorestoration

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

30 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-08-31

Primary Completion

2019-01-08

Completion

2019-01-08

Countries

• United States

Study Locations