Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Phase I:
Enrolls both CD patients and healthy controls.
One approximately 3 hour visit which includes:
Phase II:
Enrolls only CD patients.
Five consecutive days of study visits.
Day 1:
Days 2-4:
- 20 min tES or sham tES session
Day 5:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI - HC tDCS | Active Comparator | Healthy controls in Phase 1 transcranial electrical stimulation set to direct current |
|
| MRI - HC tACS | Active Comparator | Healthy controls in Phase 1- transcranial electrical stimulation set to alternating current |
|
| MRI - CD tCDS | Active Comparator | Cervical dystonia in Phase 1 transcranial electrical stimulation set to direct current |
|
| MRI - CD tACS | Active Comparator | Cervical dystonia in Phase 1 transcranial electrical stimulation set to alternating current |
|
| Phase II - Stim | Active Comparator | Cervical dystonia in Phase 2 transcranial electrical stimulation setting is active |
|
| Phase II - Sham |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial electrical stimulation | Device | The device is a Neoprene headcap that holds an array of padded electrodes close to the scalp to stimulate the underlying brain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Phase II: Improvement in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score | A change in TWSTRS scores following five daily sessions of inhibitory tACS. | Day 1, Day 5 |
Not provided
Not provided
Primary Cervical Dystonia
Inclusion Criteria:
Exclusion Criteria:
Healthy Controls
Inclusion Criteria:
- Right-handed
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian Berman, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 29, 2022 | Sep 21, 2022 | 7 |
| ID | Term |
|---|---|
| C566572 | Cervical Dystonia, Primary |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham Comparator |
Cervical dystonia in Phase 2 transcranial electrical stimulation setting is sham |
|
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |