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

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

— Post-coma DBS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01718249
• Other study ID #: CHU-0126
• Secondary ID: 2011-A00300-41
• Status: Completed
• Phase: N/A
• First received: October 29, 2012
• Last updated: November 22, 2017
• Start date: April 2012
• Est. completion date: April 2016

Study information

• Verified date: November 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Implantable neurostimulation system

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Fondation de l'Avenir, Medtronic

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRS-R scores (Coma Recovery Scale-Revised)		after 2 months and after 7 months
Secondary	signs of awakening at night		during the 10 months of the study
Secondary	zerit burden interview		at 1 month and at 10 months