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Transcranial Electrical Stimulation for Cervical Dystonia

Primary Purpose

Primary Cervical Dystonia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcranial electrical stimulation
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Primary Cervical Dystonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Colorado Denver

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Sham Comparator

Arm Label

MRI - HC tDCS

MRI - HC tACS

MRI - CD tCDS

MRI - CD tACS

Phase II - Stim

Phase II - Sham

Arm Description

Healthy controls in Phase 1 transcranial electrical stimulation set to direct current

Healthy controls in Phase 1- transcranial electrical stimulation set to alternating current

Cervical dystonia in Phase 1 transcranial electrical stimulation set to direct current

Cervical dystonia in Phase 1 transcranial electrical stimulation set to alternating current

Cervical dystonia in Phase 2 transcranial electrical stimulation setting is active

Cervical dystonia in Phase 2 transcranial electrical stimulation setting is sham

Outcomes

Primary Outcome Measures

Phase I: A change in brain functional connectivity in primary cervical dystonia
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.
Phase II: Improvement in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score
A change in TWSTRS scores following five daily sessions of inhibitory tACS.

Secondary Outcome Measures

Full Information

First Posted
November 29, 2017
Last Updated
April 21, 2022
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT03369613
Brief Title
Transcranial Electrical Stimulation for Cervical Dystonia
Official Title
Transcranial Electrical Stimulation (tES) for the Treatment of Cervical Dystonia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 27, 2017 (Actual)
Primary Completion Date
September 20, 2021 (Actual)
Study Completion Date
September 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Cervical Dystonia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI - HC tDCS
Arm Type
Active Comparator
Arm Description
Healthy controls in Phase 1 transcranial electrical stimulation set to direct current
Arm Title
MRI - HC tACS
Arm Type
Active Comparator
Arm Description
Healthy controls in Phase 1- transcranial electrical stimulation set to alternating current
Arm Title
MRI - CD tCDS
Arm Type
Active Comparator
Arm Description
Cervical dystonia in Phase 1 transcranial electrical stimulation set to direct current
Arm Title
MRI - CD tACS
Arm Type
Active Comparator
Arm Description
Cervical dystonia in Phase 1 transcranial electrical stimulation set to alternating current
Arm Title
Phase II - Stim
Arm Type
Active Comparator
Arm Description
Cervical dystonia in Phase 2 transcranial electrical stimulation setting is active
Arm Title
Phase II - Sham
Arm Type
Sham Comparator
Arm Description
Cervical dystonia in Phase 2 transcranial electrical stimulation setting is sham
Intervention Type
Device
Intervention Name(s)
transcranial electrical stimulation
Intervention Description
The device is a Neoprene headcap that holds an array of padded electrodes close to the scalp to stimulate the underlying brain.
Primary Outcome Measure Information:
Title
Phase I: A change in brain functional connectivity in primary cervical dystonia
Description
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.
Time Frame
Day 1
Title
Phase II: Improvement in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score
Description
A change in TWSTRS scores following five daily sessions of inhibitory tACS.
Time Frame
Day 1, Day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Berman, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

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Transcranial Electrical Stimulation for Cervical Dystonia

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