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

NCT ID: NCT01718249

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2016-04-30

Brief Summary

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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

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

Conditions

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

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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deep brain stimulation

Group Type OTHER

Implantable neurostimulation system

Intervention Type OTHER

Interventions

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Implantable neurostimulation system

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation de l'Avenir

OTHER

Sponsor Role collaborator

Medtronic

INDUSTRY

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Jacques LEMAIRE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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2011-A00300-41

Identifier Type: -

Identifier Source: secondary_id

CHU-0126

Identifier Type: -

Identifier Source: org_study_id