Transcranial Electrical Stimulation for Cervical Dystonia

NCT03369613 | Completed FDA Device

• 1 other identifier: 17-1322
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Cervical Dystonia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (6)

MRI - HC tDCS

ACTIVE COMPARATOR

Healthy controls in Phase 1 transcranial electrical stimulation set to direct current

Device: transcranial electrical stimulation

MRI - HC tACS

ACTIVE COMPARATOR

Healthy controls in Phase 1- transcranial electrical stimulation set to alternating current

Device: transcranial electrical stimulation

MRI - CD tCDS

ACTIVE COMPARATOR

Cervical dystonia in Phase 1 transcranial electrical stimulation set to direct current

Device: transcranial electrical stimulation

MRI - CD tACS

ACTIVE COMPARATOR

Cervical dystonia in Phase 1 transcranial electrical stimulation set to alternating current

Device: transcranial electrical stimulation

Phase II - Stim

ACTIVE COMPARATOR

Cervical dystonia in Phase 2 transcranial electrical stimulation setting is active

Device: transcranial electrical stimulation

Phase II - Sham

SHAM COMPARATOR

Cervical dystonia in Phase 2 transcranial electrical stimulation setting is sham

Device: transcranial electrical stimulation

Interventions

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.

MRI - CD tACS; MRI - CD tCDS; MRI - HC tACS; MRI - HC tDCS; Phase II - Sham; Phase II - Stim

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• \- Right-handed
• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Cervical Dystonia, Primary

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Brian Berman, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 12, 2017
• Study Start: October 27, 2017
• Primary Completion: September 20, 2021
• Study Completion: September 20, 2021
• Last Updated: April 25, 2022

Record last verified: 2022-04

Locations

US (1)