NCT02542839

rTMS and Botulinum Toxin in Primary Cervical Dystonia

Combined Therapy With rTMS and Botulinum Toxin in Primary Cervical Dystonia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

rTMS refers to the application of transcranial magnetic stimulation (TMS) pulses to a specific target at predefined stimulation parameters. Repeated sessions of rTMS therapy have been demonstrated to induce cumulative persistent benefits that can last weeks after the conclusion of the rTMS sessions The central hypothesis of this study is that rTMS therapy in PCD can potentiate the effects of BoNT injections. With the current standard treatment, the peak-dose benefits seen with BoNT are seen at about 4-6 weeks after the administration of injections. The investigator will introduce a 1 week course of rTMS around 2-8 weeks before or after BoNT or T1). The investigator will examine the effects of combined therapy at 10 weeks after BoNT and 12 weeks after BoNT injections follow-up.

Conditions

• Primary Cervical Dystonia
• Dystonia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-11-01
• Primary completion: 2021-06-28
• Completion: 2021-06-28
• First posted: 2015-09-07
• Last updated: 2023-12-22
• Results posted: 2023-09-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study