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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of New Mexico
Sponsor:
Collaborators:
Dystonia Coalition
University Health Network, Toronto
Information provided by (Responsible Party):
Sarah Pirio Richardson, University of New Mexico
ClinicalTrials.gov Identifier:
NCT01859247
First received: May 9, 2013
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Cervical Dystonia
Spasmodic Torticollis
Device: rTMS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Identification of Optimal Stimulation Site for Cervical Dystonia Symptoms: An Exploratory Study

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) [ Time Frame: Change from baseline pre-intervention TWSTRS score to post-intervention within 1 hour of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dorsal Premotor-motor inhibition (dPMI) [ Time Frame: Change from baseline dPMI to post-intervention within 1 hour of treatment ] [ Designated as safety issue: No ]
  • Composite measure of patient rating of symptoms and tolerability [ Time Frame: Change from baseline dPMI to post-intervention within 1 hour of treatment ] [ Designated as safety issue: No ]
    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."


Estimated Enrollment: 7
Study Start Date: March 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dorsal Premotor rTMS
0.2 Hz rTMS for 15 minutes
Device: rTMS
Active Comparator: Primary motor cortex rTMS
0.2 Hz rTMS for 15 minutes
Device: rTMS
Active Comparator: Supplemental Motor Area rTMS
0.2 Hz rTMS for 15 minutes
Device: rTMS
Active Comparator: Anterior Cingulate rTMS
0.2 Hz rTMS for 15 minutes
Device: rTMS
Sham Comparator: Sham rTMS
0.2 Hz rTMS for 15 minutes
Device: rTMS

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01859247

Contacts
Contact: Meg Radigan 505-272-8740 mradigan@salud.unm.edu

Locations
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Meg Radigan       mradigan@salud.unm.edu   
Principal Investigator: Sarah Pirio Richardson, MD         
Sub-Investigator: Meg Radigan         
Sponsors and Collaborators
University of New Mexico
Dystonia Coalition
University Health Network, Toronto
Investigators
Principal Investigator: Sarah Pirio Richardson, MD University of New Mexico
Study Director: H.A. Jinnah, MD Emory University
  More Information

Additional Information:
Publications:
Responsible Party: Sarah Pirio Richardson, MD, University of New Mexico
ClinicalTrials.gov Identifier: NCT01859247     History of Changes
Other Study ID Numbers: UNM 657, U54NS065701
Study First Received: May 9, 2013
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
cervical dystonia
torticollis
rTMS

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on July 20, 2014