Repetitive Transcranial Magnetic Stimulation (rTMS) for Dystonia and Tremor

Changes in Cortical Oscillations Induced by Repetitive Transcranial Magnetic Stimulation (rTMS) Therapy in Patient Populations With Tremor

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.

Study Overview

• Status: Completed
• Conditions: Dystonia; Tremor
• Intervention / Treatment: Device: repetitive Transcranial Magnetic Stimulation (rTMS); Other: Control group

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for Dystonia and/or tremor:

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

Exclusion Criteria Dystonia and/or tremor:

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

Inclusion Criteria for Healthy controls

- There is no history of any neurological disorders.

Exclusion Criteria for Healthy controls

• Pregnancy
• Any neurological disorders
• Presence of a metallic body in their brain
• History of stroke

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dystonia and/or tremor; Adults with a diagnosis of dystonia and/or tremor	Device: 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.
Experimental: 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	Other: Control group; No application of rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Assessment Using MoCA Version 7.1 Scores	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.	Day 1

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: David Vaillancourt, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2020
• Primary Completion (Actual): August 11, 2022
• Study Completion (Actual): August 11, 2022

Study Registration Dates

• First Submitted: February 28, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Dystonia; Dystonic Disorders; Tremor
• Other Study ID Numbers: IRB201902838; R01NS058487 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes