Repetitive Transcranial Magnetic Stimulation (rTMS) for Dystonia and Tremor

NCT04299087 | Completed Results DMC FDA Device

• 2 other identifiers: IRB201902838R01NS058487
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Dystonia; Tremor

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Dystonia and/or tremor

EXPERIMENTAL

Adults with a diagnosis of dystonia and/or tremor

Device: repetitive Transcranial Magnetic Stimulation (rTMS)

Control

EXPERIMENTAL

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

Interventions

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.

Dystonia and/or tremor

Control group OTHER

No application of rTMS

Control

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Active seizure disorder
• Presence of a metallic object such as a pacemaker, implants, metal rods, and hearing aid
• History of stroke
• \- There is no history of any neurological disorders.
• Pregnancy
• Any neurological disorders
• Presence of a metallic body in their brain
• History of stroke

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Dystonia; Tremor

Interventions

Transcranial Magnetic Stimulation; Control Groups

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Dr. David Vaillancourt
• Organization: University of Florida

vcourt@ufl.edu

(352) 294 - 1770

Study Officials

• David Vaillancourt, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 6, 2020
• Study Start: March 12, 2020
• Primary Completion: August 11, 2022
• Study Completion: August 11, 2022
• Last Updated: August 21, 2023
• Results First Posted: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)