Transcranial Electrical Stimulation for Cervical Dystonia

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Cervical Dystonia
• Intervention / Treatment: Device: transcranial electrical stimulation

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MRI - HC tDCS; Healthy controls in Phase 1 transcranial electrical stimulation set to direct current	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.
Active Comparator: MRI - HC tACS; Healthy controls in Phase 1- transcranial electrical stimulation set to alternating current	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.
Active Comparator: MRI - CD tCDS; Cervical dystonia in Phase 1 transcranial electrical stimulation set to direct current	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.
Active Comparator: MRI - CD tACS; Cervical dystonia in Phase 1 transcranial electrical stimulation set to alternating current	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.
Active Comparator: Phase II - Stim; Cervical dystonia in Phase 2 transcranial electrical stimulation setting is active	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.
Sham Comparator: Phase II - Sham; Cervical dystonia in Phase 2 transcranial electrical stimulation setting is sham	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Brian Berman, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2017
• Primary Completion (Actual): September 20, 2021
• Study Completion (Actual): September 20, 2021

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Dystonia; Dystonic Disorders; Torticollis
• Other Study ID Numbers: 17-1322

Drug and device information, study documents

• 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