ClinicalTrials.Veeva

Menu

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

U

University Hospital, Clermont-Ferrand

Status

Completed

Conditions

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

Treatments

Other: Implantable neurostimulation system

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01718249
2011-A00300-41
CHU-0126

Details and patient eligibility

About

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.

Full description

Total length of inclusion for a patient: 10 months (2 months before electrodes implantation, 8 months after).

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Single Blind

5 participants in 1 patient group

deep brain stimulation
Other group
Treatment:
Other: Implantable neurostimulation system

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems