Repetitive Transcranial Magnetic Stimulation (rTMS) for Dystonia and Tremor

Not Applicable

Completed

• Conditions: Tremor; Dystonia
• Interventions: Device: repetitive Transcranial Magnetic Stimulation (rTMS); Other: Control group

• Registration Number: NCT04299087
• Lead Sponsor: University of Florida

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-02-28
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-06
• Study Start: 2020-03-12
• Primary Completion: 2022-08-11
• Study Completion: 2022-08-11
• Results First Submitted: 2023-06-22
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-15
• Last Update Submitted: 2023-08-15
• Results First Posted: 2023-08-21
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dystonia and/or tremor	repetitive Transcranial Magnetic Stimulation (rTMS)	Adults with a diagnosis of dystonia and/or tremor
Control	Control group	Healthy adults without a history of any neurological disorder, with a similar age distribution and sex ratio as the dystonia and/or tremor group

Primary Outcome Measures

Name	Time	Method
Cognitive Assessment Using MoCA Version 7.1 Scores	Day 1	Montreal Cognitive Assessment Version 7.1 was used to assess cognitive ability. This scales is score from a range of 0 to 30 with a score of 24 or less indicating mild cognitive impairment. Moderate cognitive impairment is indicated by a score of 18-23 and severe impairment is a score of 10 or less. Overall, a higher number indicates better cognitive ability.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States