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CompletedNCT01718249Post-coma DBSUpdated Aug 5, 2026

Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness

An interventional study of Implantable neurostimulation system in Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State), sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Apr 2012, registered Oct 2012).
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State)

Keywords

  • Deep Brain Stimulation (DBS)
  • Post-coma
  • Consciousness
  • Vegetative state
  • Minimally conscious state
03

In context

Bronchiolitis Obliterans Syndrome

714 studies on the registry are indexed under Bronchiolitis Obliterans Syndrome; 128 are open to participants now.

This study's enrollment of 5 is below the median of 50 across 565 interventional studies indexed under Bronchiolitis Obliterans Syndrome.

Browse Bronchiolitis Obliterans Syndrome studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.

Browse University Hospital, Clermont-Ferrand studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients stably in Vegetative state or Minimally conscious state, since at least 6 months after cerebrovascular accident and 1 year after traumatic brain injury.

Exclusion criteria

Exclusion Criteria:

  • Cerebral death, Locked-In Syndrome, blindness, deafness
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Participant)
Enrollment
5 participants (actual)

Study arms

  • Other
    deep brain stimulation

    Other: Implantable neurostimulation system

Interventions

  • OtherImplantable neurostimulation system
06

What researchers measure

Primary outcomes

  1. CRS-R scores (Coma Recovery Scale-Revised)

    Time frame: after 2 months and after 7 months

Secondary outcomes

  1. signs of awakening at night

    Time frame: during the 10 months of the study

  2. zerit burden interview

    Time frame: at 1 month and at 10 months

07

Study locations

1 site
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2012 to primary completion in Apr 2016, 48 months.

Of 110 non-industry interventional studies with no phase under Bronchiolitis Obliterans Syndrome, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's 48 months is above that.

Counting every sponsor, half of 122 studies reached it within 22 months; a quarter within 11 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2012
First posted
Oct 31, 2012
StartActual
Apr 2012
Primary completionActual
Apr 2016
CompletionActual
Apr 2016
Last update
Aug 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01718249
Lead sponsor
University Hospital, Clermont-Ferrand
Collaborators
Fondation de l'Avenir, Medtronic
Responsible party
Sponsor
First posted
Oct 31, 2012
Start date
Apr 2012
Primary completion
Apr 2016
Completion
Apr 2016
Last update
Aug 5, 2026

Study contacts

Jean-Jacques LEMAIRE
principal investigator · University Hospital, Clermont-Ferrand
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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