Transcranial Electrical Stimulation for Cervical Dystonia

Primary Cervical Dystonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03369613
• Other study ID #: 17-1322
• Status: Completed
• Phase: N/A
• Start date: October 27, 2017
• Est. completion date: September 20, 2021

Study information

• Verified date: April 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Primary Cervical Dystonia
• Torticollis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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