Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State)Post-coma DBSNCT01718249
Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness
A study testing Implantable neurostimulation system in people with Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State), run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Chronic post-coma consciousness impairment is a severe handicap. Preliminary studies suggest that deep brain stimulation of the thalamic-tegmental reticular system could improve consciousness disorders, and facilitate the emergence of conscious behavior. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State)
- What is being tested?
- Implantable neurostimulation system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2012to Apr 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients stably in Vegetative state or Minimally conscious state, since at least 6 months after cerebrovascular accident and 1 year after traumatic brain injury.
Who cannot join
- Cerebral death, Locked-In Syndrome, blindness, deafness
Trial locations and contacts
1 site in 1 country.
About this study
Chronic post-coma consciousness impairment is a severe handicap. Preliminary studies suggest that deep brain stimulation of the thalamic-tegmental reticular system could improve consciousness disorders, and facilitate the emergence of conscious behavior. The aim of this protocol is to study the effects of deep brain stimulation on conscious behavior, using a patient-based anatomic mapping for stereotactic surgery, and the Coma Recovery Scale-Revised (CRS-R) as clinical assessment criterion.
Read the detailed description
Total length of inclusion for a patient: 10 months (2 months before electrodes implantation, 8 months after).
- Being tested
- Implantable neurostimulation system
- Keywords
- Deep Brain Stimulation (DBS), Post-coma, Consciousness, Vegetative state, Minimally conscious state
- Medical subject headings
- Bronchiolitis Obliterans Syndrome, Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable neurostimulation systemOther
| Study group | Role | What they receive |
|---|---|---|
| deep brain stimulation | Other | Not described Receives: Other: Implantable neurostimulation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRS-R scores (Coma Recovery Scale-Revised)
Measured: after 2 months and after 7 months
Secondary outcomes (2)
signs of awakening at night
Measured: during the 10 months of the study
zerit burden interview
Measured: at 1 month and at 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de l'Avenir, Medtronic
- Responsible party
- Sponsor
- Investigators
- Jean-Jacques LEMAIRE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718249
- Sponsor's protocol ID
- CHU-0126
- Other IDs
- 2011-A00300-41
- Acronym
- Post-coma DBS
- Status last verified
- Aug 2026
- First submitted
- 29 Oct 2012
- Last updated
- 5 Aug 2026
- Results posted
- No
Publications
Lemaire JJ, Sontheimer A, Pereira B, Coste J, Rosenberg S, Sarret C, Coll G, Gabrillargues J, Jean B, Gillart T, Coste A, Roche B, Kelly A, Pontier B, Feschet F. Deep brain stimulation in five patients with severe disorders of consciousness. Ann Clin Transl Neurol. 2018 Sep 26;5(11):1372-1384. doi: 10.1002/acn3.648. eCollection 2018 Nov.
PubMed 30480031
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT01718249
- Acronym / sponsor ID
- Post-coma DBS / CHU-0126
- Keywords
- Deep Brain Stimulation (DBS), Post-coma, Consciousness, Vegetative state, Minimally conscious state
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Fondation de l'Avenir, Medtronic
- Study start
- Apr 2012 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 31 Oct 2012 (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.
Chronic post-coma consciousness impairment is a severe handicap. Preliminary studies suggest that deep brain stimulation of the thalamic-tegmental reticular system could improve consciousness disorders, and facilitate the emergence of conscious behavior. The aim of this protocol is to study the effects of deep brain stimulation on conscious behavior, using a patient-based anatomic mapping for stereotactic surgery, and the Coma Recovery Scale-Revised (CRS-R) as clinical assessment criterion.
Detailed description
Total length of inclusion for a patient: 10 months (2 months before electrodes implantation, 8 months after).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| deep brain stimulation | Other | Other: Implantable neurostimulation system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients stably in Vegetative state or Minimally conscious state, since at least 6 months after cerebrovascular accident and 1 year after traumatic brain injury.
Key exclusion criteria (1 listed)
- Cerebral death, Locked-In Syndrome, blindness, deafness
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 |
|---|---|---|
| Implantable neurostimulation system | Other | deep brain stimulation |
Primary outcome
CRS-R scores (Coma Recovery Scale-Revised)
Time frame: after 2 months and after 7 months
2 secondary outcomes
signs of awakening at night
Time frame: during the 10 months of the study
zerit burden interview
Time frame: at 1 month and at 10 months
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 5 Aug 2026.
- Results publication: PubMed 30480031Lemaire JJ, Sontheimer A, Pereira B, Coste J, Rosenberg S, Sarret C, Coll G, Gabrillargues J, Jean B, Gillart T, Coste A, Roche B, Kelly A, Pontier B, Feschet F. Deep brain stimulation in five patients with severe disorders of consciousness. Ann Clin Transl Neurol. 2018 Sep 26;5(11):1372-1384. doi: 10.1002/acn3.648. eCollection 2018 Nov.
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.
Jean-Jacques LEMAIRE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable neurostimulation system in people with Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State), run by University Hospital, Clermont-Ferrand at 1 site in France.
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 1 inclusion and 1 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 5 Aug 2026. 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 France. 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. 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?
CRS-R scores (Coma Recovery Scale-Revised) (time frame: after 2 months and after 7 months). 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 NCT01718249, which also lists 1 linked publication.
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 5 Aug 2026.