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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01859247
Study type Interventional
Source University of New Mexico
Contact
Status Completed
Phase N/A
Start date March 2013
Completion date June 2014

See also
  Status Clinical Trial Phase
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Not yet recruiting NCT04057911 - A Trial of Non-invasive Stimulation in Cervical Dystonia N/A
Withdrawn NCT02180139 - tDCS in Cervical Dystonia N/A
Completed NCT00541905 - Daily Dystonia Practice - A Trial to Investigate NT 201, the Duration of Treatment Effect After One Injection Session and in Long-term Treatment in Cervical Dystonia Phase 4
Unknown status NCT00418925 - Efficacy of Dronabinol for the Treatment of Cervical Dystonia Phase 2
Not yet recruiting NCT05715138 - Comparison of Pallidal With Subthalamic Deep Brain Stimulation for Cervical Dystonia N/A
Completed NCT02131467 - Safety and Tolerability of Perampanel in Cervical Dystonia Phase 1/Phase 2
Completed NCT02959645 - Assessment of Brain Activities in Cervical Dystonia
Completed NCT03805152 - Abobotulinum Toxin and Neubotulinum Toxin Injection in Cerivical Dystonia Phase 3
Completed NCT04949594 - Relief of Pain in Patients With Cervical Dystonia Through the Use of Transcutaneous Electric Nerve Stimulation (TENS)
Recruiting NCT01664013 - The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients Phase 4
Completed NCT00210431 - Post Marketing Surveillance Study of Dysport
Completed NCT00447772 - Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia Phase 3
Completed NCT05157100 - Clinical Study of Ingrezza (Valbenazine) for the Treatment of Cervical Dystonia Phase 4
Completed NCT00257660 - Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia Phase 3
Completed NCT05103202 - Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin
Terminated NCT00760318 - Keppra for Cervical Dystonia Phase 2
Completed NCT00323765 - Plasticity in Cervical Dystonia N/A
Completed NCT04171258 - Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia Phase 1
Completed NCT04849988 - A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia Phase 2