tDCS on Precuneus in MCS: Repeated Stim… | Clinical Trial

Key information

Conditions

Patients in Minimally Conscious State After a Severe Brain Injury Brain Damage, Chronic Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Consciousness Disorders Craniocerebral Trauma Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Persistent Vegetative State Signs and Symptoms Stroke Trauma, Nervous System Unconsciousness Vascular Diseases Wounds and Injuries

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Positive effects of tDCS in patients in MCS was showed in a recent study published in Neurology. But the effects went down after 1 or 2 hours. To increase the lasting of the effects, a new study will evaluate the effects of tDCS on the precuneus cortex for 5 consecutive days in chronic patients in MCS.

2 sessions of 5 days of stimulation will be realized, one session will be real (anodal stimulation) and one placebo (sham stimulation). After each stimulation, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done 5 days after the end of the sessions to assess the long term effect of the tDCS.

Researchers expected to see an improvement of the CRS-R total score at the end of the anodal session and that this improvement persists for 5 days.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

post comatose patients
patients in minimally conscious state
patients with stable condition
patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)

Exclusion criteria

premorbid neurology antecedent
patients in coma or vegetative state
patients < 1 months after the acute brain injury
patients with a metallic cerebral implant or a pacemaker (in line with the safety criteria for tDCS in humans)

Treatment and study plan

Transcranial Direct Current Stimulation

Device

anodal transcranial direct current stimulation on the precuneus cortex for the anodal session and sham stimulation (5secondes of tDCS) for the sham session.

Primary outcomes

Change in the CRS-R total score

Time frame: After each stimulation and 5 days later for anodal and sham sessions (total: 1 month)

Improvement of the CRS-R total score after the end of the anodal session and 5 days later but no change for the sham session

Secondary outcomes

Influence of the time since insult

Time frame: one month

Influence of the time since insult of the results. Researchers expected that the longer a patient is in MCS, the lower is his/her improvement after the tDCS session.

Sponsors and collaborators

Lead sponsor

Hangzhou Normal University

Other

Registry information

Official study title

Repeated Stimulation of the Precuneus in Chronic Patients in Minimally Conscious State: a Placebo-controlled Randomized Clinical Trial

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Mar 8, 2016
Registry last updated: Mar 8, 2016

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.

Published trials that share one or more normalized conditions with this study.

Completed