Identification of Optimal Stimulation Site for Cervical Dystonia Symptoms: An Exploratory Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cervical Dystonia
- Sponsor
- University of New Mexico
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The overall objective of this application is to therapeutically target the dysfunctional premotor-motor interaction in dystonia-and to provide a focused treatment of specific anatomical networks in order to reduce side effects and to improve symptom control over conventional therapies.
Detailed Description
We propose using repetitive transcranial magnetic stimulation (rTMS) over distinct premotor areas in patients with cervical dystonia (CD) with the goal of improving symptoms and reducing unwanted side effects. The knowledge gained in this proposed research will identify a specific premotor area to be targeted with rTMS that is expected to result in a novel intervention that could enhance or replace current treatments for CD. rTMS could be included as an adjunct treatment to botulinum toxin that could sustain treatment effect and decrease the frequency of re-injection, potentially resulting in cost savings without a decrease in symptom control. In addition to medical cost reduction, improved quality of life could be expected with the successful development of therapies that extend dystonia symptom control. rTMs has been FDA-approved for the treatment of depression and our proposal uses an even lower stimulation rate, suggesting continued use within clearly safe parameters. Successful completion of this research could lead to rapid adoption of this therapeutic modality. We will test the hypothesis that rTMS of a distinct premotor site will provide more effective treatment of CD than non-specific activation of the entire premotor region. This will be done by performing a randomized, observer-blinded exploratory pilot study to determine the optimal site of rTMS over various sites of the premotor and motor cortex to improve the symptoms of cervical dystonia. Completion of this aim should lead to development of targeted TMS therapy for CD.
Investigators
Sarah Pirio Richardson
MD
University of New Mexico
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of idiopathic cervical dystonia
- •Age 18 years or older
- •Normal findings in the medical history, physical and neurological examination, except for dystonia
- •Last treatment with botulinum toxin more than two months ago
Exclusion Criteria
- •History of seizure disorder
- •Pregnancy- a pregnancy test will be performed for women of childbearing potential
- •History of any other neurological disorders or conditions requiring the use of anti-depressants that are known to increase seizure threshold, neuroleptic medication, anticholinergic drugs and muscle relaxants
- •History of neuroleptic medications/ prior use of neuroleptics
Outcomes
Primary Outcomes
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Time Frame: Change from baseline pre-intervention TWSTRS score to post-intervention within 1 hour of treatment
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was used to assess severity of disease. The score for this section ranges from 0 (absence of severity) to 35 (maximum severity).
Secondary Outcomes
- Dorsal Premotor-motor Inhibition (dPMI)(Change from baseline dPMI to post-intervention within 1 hour of treatment)
- Composite Measure of Patient Rating of Symptoms and Tolerability(Assessment completed immediately after rTMS treatment session)