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NCT Number: NCT01718249

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

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.

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Key information

Conditions

Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State) Brain Damage, Chronic Brain Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Central Nervous System Diseases Consciousness Disorders Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Organizing Pneumonia Pathological Conditions, Signs and Symptoms Persistent Vegetative State Respiratory Tract Diseases Signs and Symptoms Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantable neurostimulation system

Other

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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Fondation de l'Avenir
  • Medtronic

Registry information

Acronym: Post-coma DBS

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 31, 2012
Registry last updated
Nov 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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