Disorder of ConsciousnessNCT03114397
Long-term Effect of tDCS in Patients With Disorders of Consciousness
A study testing transcranial direct current stimulation - active in people with Disorder of Consciousness, run by University of Liege at 1 site in Belgium.
Trial summary
In this multicentric double-blind sham controlled study, the investigators plan to assess the effects of 20 sessions of tDCS on long-term behavioral recovery in patients with disorders of consciousness. Neurophysiological outcomes (EEG) will also be collected. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Disorder of Consciousness
- What is being tested?
- transcranial direct current stimulation - active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2017to 24 Dec 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- CNS medication stable for at least a week
- Stable diagnosis (no diagnosis change based on 2 CRS-R performed within 1 week).
- Between 3 and 24 months post injury
- Structural MRI or CT-scan (to evidence focal lesions on the left DLPFC)
Who cannot join
- Craniotomies encompassing the frontal region (electrodes location)
- VPS under the stimulated area (prefrontal cortex)
- Pacemaker
- Metallic cerebral implant
- Severe medical conditions that might influence clinical diagnosis and EEG activity (e.g., severe hepatic insufficiency or renal failure, or sub-continuous or abundant epileptiform discharges on standard EEG recordings).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Effect of 20 Sessions of Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness: a Double Blind Sham Controlled Clinical Trial.
In this multicentric double-blind sham controlled study, the investigators plan to assess the effects of 20 sessions of tDCS on long-term behavioral recovery in patients with disorders of consciousness. Neurophysiological outcomes (EEG) will also be collected.
This research will 1) determine whether long-term behavioral recovery can be promoted with tDCS and 2) generate knowledge regarding the impact of tDCS on neurophysiological outcome (i.e., EEG) in severely brain injured patients. The investigators will compare the effects of active and sham tDCS on behavioral assessments and quantitative EEG in patients with severe brain injury and its potential application in rehabilitation.
- Conditions
- Disorder of Consciousness
- Being tested
- transcranial direct current stimulation - active, transcranial direct current stimulation - sham
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation - activeDevice
transcranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes.
transcranial direct current stimulation - shamDevice
transcranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes. The sham intervention consists of 30 seconds of stimulation at the beginning and the end of the 20minutes of intervention.
| Study group | Role | What they receive |
|---|---|---|
| anodal stimulation | Active comparator | Patients will receive anodal tDCS (on the left dorsolateral prefrontal cortex) every day for 4 weeks, 5 days per week (tDCS of 2mA during 20minutes) for a total of 20 sessions. Receives: Device: transcranial direct current stimulation - active |
| sham stimulation | Placebo comparator | Patients will receive sham tDCS (on the left dorsolateral prefrontal cortex) every day for 4 weeks, 5 days per week (tDCS of 2mA during 20minutes) for a total of 20 sessions. Receives: Device: transcranial direct current stimulation - sham |
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start1 Sep 2017
- Primary completion24 Dec 2021
- Study completion24 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Disorder of ConsciousnessStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Salvatore Maugeri, Italy, Université Catholique de Louvain, Hospitales Nisa, Spain, I.R.C.C.S. Fondazione Santa Lucia, Italy, Schoen Clinic Bad Aibling, Germany, Research Center of Neurology, Russia, Therapiezentrum Burgau, Germany, pavlov state medical university, Russia, Azienda Unita Sanitaria Locale di Piacenza
- Responsible party
- Principal investigator, Aurore Thibaut, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114397
- Sponsor's protocol ID
- 2014/113b
- Status last verified
- Nov 2022
- First submitted
- 29 Mar 2017
- Last updated
- 3 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thibaut A, Wannez S, Donneau AF, Chatelle C, Gosseries O, Bruno MA, Laureys S. Controlled clinical trial of repeated prefrontal tDCS in patients with chronic minimally conscious state. Brain Inj. 2017;31(4):466-474. doi: 10.1080/02699052.2016.1274776. Epub 2017 Mar 10.
PubMed 28281845Thibaut A, Bruno MA, Ledoux D, Demertzi A, Laureys S. tDCS in patients with disorders of consciousness: sham-controlled randomized double-blind study. Neurology. 2014 Apr 1;82(13):1112-8. doi: 10.1212/WNL.0000000000000260. Epub 2014 Feb 26.
PubMed 24574549
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effect of 20 Sessions of Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness: a Double Blind Sham Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03114397
- Acronym / sponsor ID
- 2014/113b
- Conditions
- Disorder of Consciousness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- Fondazione Salvatore Maugeri, Italy, Université Catholique de Louvain, Hospitales Nisa, Spain, I.R.C.C.S. Fondazione Santa Lucia, Italy, Schoen Clinic Bad Aibling, Germany, Research Center of Neurology, Russia, Therapiezentrum Burgau, Germany, pavlov state medical university, Russia, Azienda Unita Sanitaria Locale di Piacenza
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 24 Dec 2021 (actual)
- Study completion
- 24 Dec 2021 (actual)
- First posted
- 14 Apr 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.
In this multicentric double-blind sham controlled study, the investigators plan to assess the effects of 20 sessions of tDCS on long-term behavioral recovery in patients with disorders of consciousness. Neurophysiological outcomes (EEG) will also be collected.
This research will 1) determine whether long-term behavioral recovery can be promoted with tDCS and 2) generate knowledge regarding the impact of tDCS on neurophysiological outcome (i.e., EEG) in severely brain injured patients. The investigators will compare the effects of active and sham tDCS on behavioral assessments and quantitative EEG in patients with severe brain injury and its potential application in rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anodal stimulation | Active comparator | Device: transcranial direct current stimulation - activePatients will receive anodal tDCS (on the left dorsolateral prefrontal cortex) every day for 4 weeks, 5 days per week (tDCS of 2mA during 20minutes) for a total of 20 sessions. |
| sham stimulation | Placebo comparator | Device: transcranial direct current stimulation - shamPatients will receive sham tDCS (on the left dorsolateral prefrontal cortex) every day for 4 weeks, 5 days per week (tDCS of 2mA during 20minutes) for a total of 20 sessions. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- CNS medication stable for at least a week
- Stable diagnosis (no diagnosis change based on 2 CRS-R performed within 1 week).
- Between 3 and 24 months post injury
- Structural MRI or CT-scan (to evidence focal lesions on the left DLPFC)
Key exclusion criteria (5 listed)
- Craniotomies encompassing the frontal region (electrodes location)
- VPS under the stimulated area (prefrontal cortex)
- Pacemaker
- Metallic cerebral implant
- Severe medical conditions that might influence clinical diagnosis and EEG activity (e.g., severe hepatic insufficiency or renal failure, or sub-continuous or abundant epileptiform discharges on standard EEG recordings).
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 stimulation - activetranscranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes. | Device | anodal stimulation |
| transcranial direct current stimulation - shamtranscranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes. The sham intervention consists of 30 seconds of stimulation at the beginning and the end of the 20minutes of intervention. | Device | sham stimulation |
Primary outcome
Change in the CRS-R total score
Time frame: 4 weeks
Improvement of the CRS-R total score after the end of the anodal session.
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 3 Nov 2022.
- Background: PubMed 28281845Thibaut A, Wannez S, Donneau AF, Chatelle C, Gosseries O, Bruno MA, Laureys S. Controlled clinical trial of repeated prefrontal tDCS in patients with chronic minimally conscious state. Brain Inj. 2017;31(4):466-474. doi: 10.1080/02699052.2016.1274776. Epub 2017 Mar 10.
- Background: PubMed 24574549Thibaut A, Bruno MA, Ledoux D, Demertzi A, Laureys S. tDCS in patients with disorders of consciousness: sham-controlled randomized double-blind study. Neurology. 2014 Apr 1;82(13):1112-8. doi: 10.1212/WNL.0000000000000260. Epub 2014 Feb 26.
Related trials for Disorder of Consciousness
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Recruiting
Comprehensive Assessment of Rehabilitation Experience Using the SAFE Scale
Caregiver Anxiety, Acquired Brain Injury
RecruitingObservational study
Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage (ICH)
Recruiting
Heat and Mental Health - PART 2
Depressed Mood, Young Adults
Enrolling by invitationObservational study
A Speaking-Valve-Based Decannulation Protoco for Patients With a Prolonged Disorders of Consciousness
Prolonged Disorders of Consciousness, Tracheostomy
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.
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 direct current stimulation - active in people with Disorder of Consciousness, run by University of Liege at 1 site in Belgium.
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 5 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 3 Nov 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 Belgium. 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?
Change in the CRS-R total score (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03114397, which also lists 2 linked publications.
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 3 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.