Clinical trial NCT03369613: Transcranial Electrical Stimulation for Cervical Dystonia
Official title: Transcranial Electrical Stimulation (tES) for the Treatment of Cervical Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Cervical Dystonia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-12-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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

Primary outcomes:
measure: Phase I: A change in brain functional connectivity in primary cervical dystonia
timeFrame: Day 1
measure: Phase II: Improvement in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score
timeFrame: Day 1, Day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Brian Berman, MD
role: PRINCIPAL_INVESTIGATOR
References: