rTMS and Botulinum Toxin in Primary Cervical Dystonia

Summary

Primary cervical dystonia (PCD) is the most common form of focal dystonia. PCD is frequently reported as a source of disability, decreased quality of life, and social stigma. Botulinum toxin (BoNT) is the gold standard treatment for PCD. The average duration of benefits from BoNT injections was about 9.5 weeks and BoNT treatment is known to provide only pure symptomatic benefits and does not seem to modify the disease pathophysiology.

The investigator plans to use repetitive transcranial magnetic stimulation (rTMS) therapy as an adjunctive therapy in combination with BoNT injections as a novel approach to treat PCD. The primary goal of this study is to compare standard treatment with BoNT versus BoNT combined with a two week course of rTMS.

Conditions

• Primary Cervical Dystonia
• Dystonia

Interventions

DEVICE

NeuroStar TMS therapy

Application of repetitious transcranial magnetic stimulation (TMS) pulses using NeuroStar device to a specific brain target at predefined stimulation parameters.

DEVICE

Sham NeuroStar TMS therapy

Same procedure as real rTMS without stimulating the cerebral cortex.

OTHER

Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)

All participants will receive a clinical assessment of dystonia severity by using the TWSTRS test.

OTHER

Craniocervical Dystonia Questionnaire (CDQ-24)

All participants will fill out the Craniocervical Dystonia Questionnaire (CDQ-24) quality of life questionnaire.

OTHER

Cerebellar-brain Inhibition (CBI)

All participants will have a measure of the cerebellar-brain inhibition(CBI) which will be conducted by using a TMS device determining the ability of the coil to activate the cerebellum.

PROCEDURE

Botulinum toxin injections

All participants will receive Botulinum toxin(BoNT) injections as part of their standard of care

Sponsors & Collaborators

• American Brain Foundation

  collaborator OTHER

• Neuronetics

  collaborator OTHER

• University of Florida

  lead OTHER

Principal Investigators

• Aparna Wagle-Shukla, M.D. · UF Center for Movement Disorders and Neurorestoration

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-11-30

Primary Completion

2021-06-28

Completion

2021-06-28

FDA Device

Yes

Countries

• United States

Study Locations