Primary Cervical DystoniaNCT03369613
Transcranial Electrical Stimulation for Cervical Dystonia
A study testing transcranial electrical stimulation in people with Primary Cervical Dystonia, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Cervical Dystonia
- What is being tested?
- transcranial electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2017to 20 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Right-handed
Who cannot join
- 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
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- Healthy Controls
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: 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.
Read the 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
- Being tested
- transcranial electrical stimulation
- Medical subject headings
- Cervical Dystonia, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial electrical stimulationDevice
The device is a Neoprene headcap that holds an array of padded electrodes close to the scalp to stimulate the underlying brain.
| Study group | Role | What they receive |
|---|---|---|
| MRI - HC tDCS | Active comparator | Healthy controls in Phase 1 transcranial electrical stimulation set to direct current Receives: Device: transcranial electrical stimulation |
| MRI - HC tACS | Active comparator | Healthy controls in Phase 1- transcranial electrical stimulation set to alternating current Receives: Device: transcranial electrical stimulation |
| MRI - CD tCDS | Active comparator | Cervical dystonia in Phase 1 transcranial electrical stimulation set to direct current Receives: Device: transcranial electrical stimulation |
| MRI - CD tACS | Active comparator | Cervical dystonia in Phase 1 transcranial electrical stimulation set to alternating current Receives: Device: transcranial electrical stimulation |
| Phase II - Stim | Active comparator | Cervical dystonia in Phase 2 transcranial electrical stimulation setting is active Receives: Device: transcranial electrical stimulation |
| Phase II - Sham | Sham comparator | Cervical dystonia in Phase 2 transcranial electrical stimulation setting is sham Receives: Device: transcranial electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1, Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start27 Oct 2017
- Primary completion20 Sep 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Cervical DystoniaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Berman, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369613
- Sponsor's protocol ID
- 17-1322
- Status last verified
- Apr 2022
- First submitted
- 29 Nov 2017
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Electrical Stimulation (tES) for the Treatment of Cervical Dystonia
- ClinicalTrials.gov ID
- NCT03369613
- Acronym / sponsor ID
- 17-1322
- Conditions
- Primary Cervical Dystonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MRI - HC tDCS | Active comparator | Device: transcranial electrical stimulationHealthy controls in Phase 1 transcranial electrical stimulation set to direct current |
| MRI - HC tACS | Active comparator | Device: transcranial electrical stimulationHealthy controls in Phase 1- transcranial electrical stimulation set to alternating current |
| MRI - CD tCDS | Active comparator | Device: transcranial electrical stimulationCervical dystonia in Phase 1 transcranial electrical stimulation set to direct current |
| MRI - CD tACS | Active comparator | Device: transcranial electrical stimulationCervical dystonia in Phase 1 transcranial electrical stimulation set to alternating current |
| Phase II - Stim | Active comparator | Device: transcranial electrical stimulationCervical dystonia in Phase 2 transcranial electrical stimulation setting is active |
| Phase II - Sham | Sham comparator | Device: transcranial electrical stimulationCervical dystonia in Phase 2 transcranial electrical stimulation setting is sham |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- Right-handed
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial electrical stimulationThe device is a Neoprene headcap that holds an array of padded electrodes close to the scalp to stimulate the underlying brain. | Device | MRI - CD tACS, MRI - CD tCDS, MRI - HC tACS, MRI - HC tDCS, Phase II - Sham, Phase II - Stim |
Primary outcome
Phase I: A change in brain functional connectivity in primary cervical dystonia
Time frame: 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.
Phase II: Improvement in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score
Time frame: Day 1, Day 5
A change in TWSTRS scores following five daily sessions of inhibitory tACS.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Berman, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial electrical stimulation in people with Primary Cervical Dystonia, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: A change in brain functional connectivity in primary cervical dystonia (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.