Transcranial Electrical Stimulation for Cervical Dystonia

Not Applicable

Completed

• Conditions: Primary Cervical Dystonia
• Interventions: Device: transcranial electrical stimulation

• Registration Number: NCT03369613
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-10-27
• Study First Submitted: 2017-11-29
• Study First Submitted QC: 2017-12-08
• Study First Posted: 2017-12-12
• Primary Completion: 2021-09-20
• Study Completion: 2021-09-20
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MRI - HC tACS	transcranial electrical stimulation	Healthy controls in Phase 1- transcranial electrical stimulation set to alternating current
MRI - CD tCDS	transcranial electrical stimulation	Cervical dystonia in Phase 1 transcranial electrical stimulation set to direct current
MRI - HC tDCS	transcranial electrical stimulation	Healthy controls in Phase 1 transcranial electrical stimulation set to direct current
Phase II - Stim	transcranial electrical stimulation	Cervical dystonia in Phase 2 transcranial electrical stimulation setting is active
MRI - CD tACS	transcranial electrical stimulation	Cervical dystonia in Phase 1 transcranial electrical stimulation set to alternating current
Phase II - Sham	transcranial electrical stimulation	Cervical dystonia in Phase 2 transcranial electrical stimulation setting is sham

Primary Outcome Measures

Name	Time	Method
Phase II: Improvement in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score	Day 1, Day 5	A change in TWSTRS scores following five daily sessions of inhibitory tACS.
Phase I: A change in brain functional connectivity in primary cervical dystonia	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.

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States