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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University of New Mexico

Current Primary Outcome: 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).


Original Primary Outcome: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) [ Time Frame: Change from baseline pre-intervention TWSTRS score to post-intervention within 1 hour of treatment ]

Current Secondary Outcome:

  • Dorsal Premotor-motor Inhibition (dPMI) [ Time Frame: Change from baseline dPMI to post-intervention within 1 hour of treatment ]
  • Composite Measure of Patient Rating of Symptoms and Tolerability [ Time Frame: 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."


Original Secondary Outcome:

  • Dorsal Premotor-motor Inhibition (dPMI) [ Time Frame: Change from baseline dPMI to post-intervention within 1 hour of treatment ]
  • Composite Measure of Patient Rating of Symptoms and Tolerability [ Time Frame: Change from baseline dPMI to post-intervention within 1 hour of treatment ]
    This measure will confirm the intervention tolerability by the patient. He/she will score the tolerability from 0-10, 0 being "completely tolerable" and 10 "completely untolerable."


Information By: University of New Mexico

Dates:
Date Received: May 9, 2013
Date Started: March 2013
Date Completion:
Last Updated: June 16, 2016
Last Verified: June 2016