Patients in Minimally Conscious State After a Severe Brain InjuryPhase 2NCT02702362
tDCS on Precuneus in MCS: Repeated Stimulations
A Phase 2 study testing transcranial direct current stimulation in people with Patients in Minimally Conscious State After a Severe Brain Injury, run by Hangzhou Normal University.
Trial summary
In this study researchers will apply transcranial direct current stimulation (tDCS) for 5 consecutive days in chronic patients in minimally conscious state (MCS). Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Patients in Minimally Conscious State After a Severe Brain Injury
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Aug 2015
- Phase
- Phase 2
- 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- post comatose patients
- patients in minimally conscious state
- patients with stable condition
- patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)
Who cannot join
- premorbid neurology antecedent
- patients in coma or vegetative state
- patients < 1 months after the acute brain injury
- patients with a metallic cerebral implant or a pacemaker (in line with the safety criteria for tDCS in humans)
About this study
Official title: Repeated Stimulation of the Precuneus in Chronic Patients in Minimally Conscious State: a Placebo-controlled Randomized Clinical Trial
In this study researchers will apply transcranial direct current stimulation (tDCS) for 5 consecutive days in chronic patients in minimally conscious state (MCS).
Read the detailed description
Positive effects of tDCS in patients in MCS was showed in a recent study published in Neurology. But the effects went down after 1 or 2 hours. To increase the lasting of the effects, a new study will evaluate the effects of tDCS on the precuneus cortex for 5 consecutive days in chronic patients in MCS.
2 sessions of 5 days of stimulation will be realized, one session will be real (anodal stimulation) and one placebo (sham stimulation). After each stimulation, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done 5 days after the end of the sessions to assess the long term effect of the tDCS.
Researchers expected to see an improvement of the CRS-R total score at the end of the anodal session and that this improvement persists for 5 days.
- Being tested
- transcranial direct current stimulation
- Keywords
- disorders of consciousness, minimally conscious state, traumatic brain injury, stroke, transcranial direct current stimulation
- Medical subject headings
- Consciousness Disorders, Persistent Vegetative State, Brain Injuries, Traumatic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
anodal transcranial direct current stimulation on the precuneus cortex for the anodal session and sham stimulation (5secondes of tDCS) for the sham session.
| Study group | Role | What they receive |
|---|---|---|
| anodal stimulation | Active comparator | Patients received anodal tDCS (on the precuneus ) every day for 5 days (tDCS of 2mA during 20minutes). A CRS-R is performed at baseline (before the first stimulation) and after each tDCS.
A final CRS-R is performed 5 days after the end of the session to assess the potential long term effects of the tDCS. Receives: Device: transcranial direct current stimulation |
| sham stimulation | Sham comparator | Patients received sham tDCS (5 secondes of stimulation) every day for 5 days. A CRS-R is performed at baseline (before the first stimulation) and after each tDCS. A final CRS-R is performed 5 days after the end of the session. Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the CRS-R total score
Improvement of the CRS-R total score after the end of the anodal session and 5 days later but no change for the sham session
Measured: After each stimulation and 5 days later for anodal and sham sessions (total: 1 month)
Secondary outcomes (1)
Influence of the time since insult
Influence of the time since insult of the results. Researchers expected that the longer a patient is in MCS, the lower is his/her improvement after the tDCS session.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startDec 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients in Minimally Conscious State After a Severe Brain InjuryStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wangshan Huang, Hangzhou Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702362
- Sponsor's protocol ID
- 2016/302/A
- Status last verified
- Mar 2016
- First submitted
- 2 Mar 2016
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Stimulation of the Precuneus in Chronic Patients in Minimally Conscious State: a Placebo-controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02702362
- Acronym / sponsor ID
- 2016/302/A
- Keywords
- disorders of consciousness, minimally conscious state, traumatic brain injury, stroke, transcranial direct current stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 8 Mar 2016 (estimated)
- 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.
In this study researchers will apply transcranial direct current stimulation (tDCS) for 5 consecutive days in chronic patients in minimally conscious state (MCS).
Detailed description
Positive effects of tDCS in patients in MCS was showed in a recent study published in Neurology. But the effects went down after 1 or 2 hours. To increase the lasting of the effects, a new study will evaluate the effects of tDCS on the precuneus cortex for 5 consecutive days in chronic patients in MCS.
2 sessions of 5 days of stimulation will be realized, one session will be real (anodal stimulation) and one placebo (sham stimulation). After each stimulation, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done 5 days after the end of the sessions to assess the long term effect of the tDCS.
Researchers expected to see an improvement of the CRS-R total score at the end of the anodal session and that this improvement persists for 5 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anodal stimulation | Active comparator | Device: transcranial direct current stimulationPatients received anodal tDCS (on the precuneus ) every day for 5 days (tDCS of 2mA during 20minutes). A CRS-R is performed at baseline (before the first stimulation) and after each tDCS. A final CRS-R is performed 5 days after the end of the session to assess the potential long term effects of the tDCS. |
| sham stimulation | Sham comparator | Device: transcranial direct current stimulationPatients received sham tDCS (5 secondes of stimulation) every day for 5 days. A CRS-R is performed at baseline (before the first stimulation) and after each tDCS. A final CRS-R is performed 5 days after the end of the session. |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- post comatose patients
- patients in minimally conscious state
- patients with stable condition
- patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)
Key exclusion criteria (4 listed)
- premorbid neurology antecedent
- patients in coma or vegetative state
- patients < 1 months after the acute brain injury
- patients with a metallic cerebral implant or a pacemaker (in line with the safety criteria for tDCS in humans)
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 direct current stimulationanodal transcranial direct current stimulation on the precuneus cortex for the anodal session and sham stimulation (5secondes of tDCS) for the sham session. | Device | anodal stimulation, sham stimulation |
Primary outcome
Change in the CRS-R total score
Time frame: After each stimulation and 5 days later for anodal and sham sessions (total: 1 month)
Improvement of the CRS-R total score after the end of the anodal session and 5 days later but no change for the sham session
1 secondary outcome
Influence of the time since insult
Time frame: one month
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 8 Mar 2016.
Related trials for Patients in Minimally Conscious State After a Severe Brain Injury
Recruiting
Ultrasound Stimulation for Patients in a Disorder of Consciousness
Consciousness Disorders, Disorders of Consciousness Due to Severe Brain Injury
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing transcranial direct current stimulation in people with Patients in Minimally Conscious State After a Severe Brain Injury, run by Hangzhou Normal University.
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 4 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 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in the CRS-R total score (time frame: After each stimulation and 5 days later for anodal and sham sessions (total: 1 month)). 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 8 Mar 2016.