Identification of Optimal Stimulation Site for Cervical Dystonia Symptoms: An Exploratory Study

Not Applicable

Completed

Conditions: Spasmodic Torticollis
Cervical Dystonia

Interventions: Device: rTMS

Registration Number: NCT01859247

Lead Sponsor: University of New Mexico

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 8

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham rTMS	rTMS	0.2 Hz rTMS for 15 minutes
Primary motor cortex rTMS	rTMS	0.2 Hz rTMS for 15 minutes
Supplemental Motor Area rTMS	rTMS	0.2 Hz rTMS for 15 minutes
Anterior Cingulate rTMS	rTMS	0.2 Hz rTMS for 15 minutes
Dorsal Premotor rTMS	rTMS	0.2 Hz rTMS for 15 minutes

Primary Outcome Measures

Name	Time	Method
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)	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 Outcome Measures

Name	Time	Method
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	This measure will confirm the intervention tolerability by the patient. He/she scored the tolerability from 0-10, 0 being "completely tolerable" and 10 "completely intolerable."