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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01859247
First Posted: May 21, 2013
Last Update Posted: July 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Dystonia Coalition
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
University Health Network, Toronto
Information provided by (Responsible Party):
Sarah Pirio Richardson, University of New Mexico
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 Sarah Pirio Richardson, 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 ]
    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:
  • 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."


Enrollment: 8
Study Start Date: March 2013
Study Completion Date: June 2014
Primary Completion Date: June 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859247


Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Dystonia Coalition
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sarah Pirio Richardson, MD, University of New Mexico
ClinicalTrials.gov Identifier: NCT01859247     History of Changes
Other Study ID Numbers: UNM 657
U54NS065701 ( U.S. NIH Grant/Contract )
First Submitted: May 9, 2013
First Posted: May 21, 2013
Results First Submitted: January 8, 2016
Results First Posted: July 28, 2016
Last Update Posted: July 28, 2016
Last Verified: June 2016

Keywords provided by Sarah Pirio Richardson, 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