Repetitive Transcranial Magnetic Stimulation (rTMS) for Dystonia and Tremor

Dystonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04299087
• Other study ID #: IRB201902838
• Secondary ID: R01NS058487
• Status: Completed
• Phase: N/A
• Start date: March 12, 2020
• Est. completion date: August 11, 2022

Study information

• Verified date: August 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 11, 2022
• Est. primary completion date: August 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Tremor

Intervention

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.

Other:
• Control group
No application of rTMS

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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