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OpenTrials
Completed

NCT Number: NCT04299087

Repetitive Transcranial Magnetic Stimulation (rTMS) for Dystonia and 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.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

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 Group

Other

No application of rTMS

Primary outcomes

  1. Cognitive Assessment Using MoCA Version 7.1 Scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 6, 2020
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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