NCT03369613

Transcranial Electrical Stimulation for Cervical Dystonia

Transcranial Electrical Stimulation (tES) for the Treatment of Cervical Dystonia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Primary Cervical Dystonia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-10-27
• Primary completion: 2021-09-20
• Completion: 2021-09-20
• First posted: 2017-12-12
• Last updated: 2022-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study