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Trial record 8 of 23 for:    Recruiting, Not yet recruiting, Available Studies | "Torticollis"

Transcranial Electrical Stimulation for Cervical Dystonia

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ClinicalTrials.gov Identifier: NCT03369613
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:

There are two phases.

Phase I: A single visit which includes a screening, clinical scales, and a MRI scan with simultaneous tES/sham tES in a randomized block design. Enrolls both Cervical Dystonia (CD) patients and healthy controls.

Phase II: 5 consecutive days of 30-90 min visits to campus for tES or sham tES. Transcranial magnetic stimulation (TMS) measures and clinical scales will also be included on Day 1 and Day 5 visits. Enrolls only CD patients.


Condition or disease Intervention/treatment Phase
Primary Cervical Dystonia Device: transcranial electrical stimulation Not Applicable

Detailed Description:

Phase I:

Enrolls both CD patients and healthy controls.

One approximately 3 hour visit which includes:

  • a screening & neurological exam,
  • clinical scales & questionnaires,
  • a (approx.) 60 min MRI scan with simultaneous tES/sham tES in a randomized block design and EMG

Phase II:

Enrolls only CD patients.

Five consecutive days of study visits.

Day 1:

  • TMS screening,
  • repeated neurological assessment and clinical scales if >1 month since MRI visit
  • 30 min TMS session with concurrent EMG
  • 20 min tES or sham tES session

Days 2-4:

- 20 min tES or sham tES session

Day 5:

  • 20 min tES or sham tES session
  • 30 min TMS session with concurrent EMG
  • repeated neurological assessment and clinical scales

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Transcranial Electrical Stimulation (tES) for the Treatment of Cervical Dystonia
Actual Study Start Date : October 27, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Active Comparator: MRI - HC tDCS
Healthy controls in Phase 1 transcranial electrical stimulation set to direct current
Device: transcranial electrical stimulation
The device is a Neoprene headcap that holds an array of padded electrodes close to the scalp to stimulate the underlying brain.

Active Comparator: MRI - HC tACS
Healthy controls in Phase 1- transcranial electrical stimulation set to alternating current
Device: transcranial electrical stimulation
The device is a Neoprene headcap that holds an array of padded electrodes close to the scalp to stimulate the underlying brain.

Active Comparator: MRI - CD tCDS
Cervical dystonia in Phase 1 transcranial electrical stimulation set to direct current
Device: transcranial electrical stimulation
The device is a Neoprene headcap that holds an array of padded electrodes close to the scalp to stimulate the underlying brain.

Active Comparator: MRI - CD tACS
Cervical dystonia in Phase 1 transcranial electrical stimulation set to alternating current
Device: transcranial electrical stimulation
The device is a Neoprene headcap that holds an array of padded electrodes close to the scalp to stimulate the underlying brain.

Active Comparator: Phase II - Stim
Cervical dystonia in Phase 2 transcranial electrical stimulation setting is active
Device: transcranial electrical stimulation
The device is a Neoprene headcap that holds an array of padded electrodes close to the scalp to stimulate the underlying brain.

Sham Comparator: Phase II - Sham
Cervical dystonia in Phase 2 transcranial electrical stimulation setting is sham
Device: transcranial electrical stimulation
The device is a Neoprene headcap that holds an array of padded electrodes close to the scalp to stimulate the underlying brain.




Primary Outcome Measures :
  1. Phase I: A change in brain functional connectivity in primary cervical dystonia [ Time Frame: Day 1 ]
    A change in mean functional connectivity between the pallidum and putamen during a resting state in CD patients during inhibitory tACS targeting the sensorimotor network.

  2. Phase II: Improvement in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score [ Time Frame: Day 1, Day 5 ]
    A change in TWSTRS scores following five daily sessions of inhibitory tACS.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Primary Cervical Dystonia

Inclusion Criteria:

  • Right-handed
  • On a stable dose of all medications used to treat dystonia for the month previous to enrollment
  • No botox injections in the 10 weeks previous to enrollment

Exclusion Criteria:

  • Any contraindication to MRI scanning, tES, or TMS (e.g pregnancy, history of seizures, significant systemic medical conditions, untreated psychiatric or neurological conditions)
  • Evidence on neurological exam of any potentially confounding neurological disorder
  • Evidence of significant cognitive impairment
  • Patients with dystonia symptoms beginning prior to the age of 18 will be excluded
  • Patients with secondary dystonia resulting from medications or that are part of another neurological disorder (e.g. Parkinson's disease) will be excluded
  • Medication that might predispose the subject to seizures

Healthy Controls

Inclusion Criteria:

- Right-handed

Exclusion Criteria:

  • Any contraindication to MRI scanning, tES, or TMS (e.g pregnancy, history of seizures, significant systemic medical conditions, untreated psychiatric or neurological conditions)
  • Evidence on neurological exam of any potentially confounding neurological disorder
  • Evidence of significant cognitive impairment
  • Medication that might predispose the subject to seizures

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): NCT03369613


Contacts
Contact: Erika Shelton 303-724-5865 erika.shelton@ucdenver.edu
Contact: Nicola Haakonsen 303-724-6351 nicola.haakonsen@ucdenver.edu

Locations
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Erika Shelton         
Principal Investigator: Brian Berman, MD, MS         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Brian Berman, MD University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03369613     History of Changes
Other Study ID Numbers: 17-1322
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

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