Repetitive Transcranial Magnetic Stimulation (rTMS) for Dystonia and Tremor

University of Florida

Status: Completed

Conditions: Tremor; Dystonia

Treatments: Device: repetitive Transcranial Magnetic Stimulation (rTMS); Other: Control group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04299087

R01NS058487 (U.S. NIH Grant/Contract)

IRB201902838

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

12 participants in 2 patient groups

Dystonia and/or tremor

Experimental group

Description:

Adults with a diagnosis of dystonia and/or tremor

Treatment:

Device: repetitive Transcranial Magnetic Stimulation (rTMS)

Control

Experimental group

Description:

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

Treatment:

Other: Control group