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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

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

Who can participate

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

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
04

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
05

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

06

Study locations

1 site
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
07

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 ↗
08

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 ↗

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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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