Repetitive Transcranial Magnetic Stimulation (rTMS) for Dystonia and Tremor

NCT ID: NCT04299087

Last Updated: 2023-08-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-12

Study Completion Date

2022-08-11

Brief Summary

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The study will include subjects diagnosed with Dystonic Tremor (DT), Essential Tremor (ET), and healthy controls in the age range of 21-80 years. Electroencephalography (EEG) will be used as the primary outcome measure. Transcranial Magnetic Stimulation (TMS) will be used over the motor cortices or cerebellar cortices as an intervention that is expected to have short-term (less than an hour) electrophysiological effects.

Detailed Description

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The primary goal of this study is to compare differences in cortical activity of patients with tremor before and after applying a session of rTMS. Specifically, the investigators will apply rTMS to the primary motor cortex (M1) as our group and others have shown abnormal function of the region. Moreover, a study shows that targeting of M1 and the dorsal premotor cortex (dPMC) with rTMS results in a trend towards improved clinical outcome in patients with focal hand dystonia and cervical dystonia. The central hypothesis of this study is that rTMS can modify cortical oscillations in patient populations with tremor and that the investigators will be able to detect these changes with the use of Electroencephalography (EEG). By applying inhibitory rTMS to the motor cortices, the investigators may expect a shift in cortical oscillations towards normal activity.

Conditions

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Dystonia Tremor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Dystonia and/or tremor

Adults with a diagnosis of dystonia and/or tremor

Group Type EXPERIMENTAL

repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type DEVICE

Repetitive transcranial magnetic stimulation (rTMS) is a form of brain stimulation therapy using a magnet to target and stimulate certain areas of the brain.

Control

Healthy adults without a history of any neurological disorder, with a similar age distribution and sex ratio as the dystonia and/or tremor group

Group Type EXPERIMENTAL

Control group

Intervention Type OTHER

No application of rTMS

Interventions

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repetitive Transcranial Magnetic Stimulation (rTMS)

Repetitive transcranial magnetic stimulation (rTMS) is a form of brain stimulation therapy using a magnet to target and stimulate certain areas of the brain.

Intervention Type DEVICE

Control group

No application of rTMS

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- Diagnosis of Dystonia and/or tremor according to the Consensus Statement of the Movement Disorders Society


\- There is no history of any neurological disorders.

Exclusion Criteria

* Pregnancy
* Active seizure disorder
* Presence of a metallic object such as a pacemaker, implants, metal rods, and hearing aid
* History of stroke


* Pregnancy
* Any neurological disorders
* Presence of a metallic body in their brain
* History of stroke
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Vaillancourt, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R01NS058487

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201902838

Identifier Type: -

Identifier Source: org_study_id

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