Combined Therapy With rTMS and Botulinum Toxin in Primary Cervical Dystonia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Primary Cervical Dystonia
- Sponsor
- University of Florida
- Enrollment
- 9
- Locations
- 2
- Primary Endpoint
- Dystonia Severity as Assessed by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of PCD in accordance with the Consensus Statement of the Movement Disorder Society
- •Subjects who report Botulinum Toxin benefits lasting 10 weeks or less only (suboptimal benefits with standard care)
Exclusion Criteria
- •Pregnancy
- •Active seizure disorder
- •Presence of a metallic body such as pacemaker, implants, metal rods and hearing aid.
Outcomes
Primary Outcomes
Dystonia Severity as Assessed by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Time Frame: absolute value at 12 weeks
A clinical assessment of dystonia severity will be conducted at each study visit using the TWSTRS. The TWSTRS is a widely accepted composite rating scale for PCD with subscales for clinical severity, functional disability, and associated pain. The total score reported here can range 0-85, where a higher scores represent greater dystonia severity.
Secondary Outcomes
- TMS Measure Referred to as Cerebellar Inhibition (CBI)(absolute value at 12 weeks)
- Craniocervical Dystonia Questionnaire(absolute value at 12 Weeks)