Effect of Repeated tDCS Sessions on Cognitive Improvement in Patients With Disorders of Consciousness

Disorders of Consciousness Clinical Trial

— rtDCS in DOC  

Official title:

Effect of Daily Left Prefrontal Dorsolateral Transcranial Direct Current Stimulation Sessions on Cognitive Improvement in Patients With Disorders of Consciousness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02394691
• Other study ID #: 2014/113
• Status: Completed
• Phase: N/A
• First received: March 11, 2015
• Last updated: March 29, 2017
• Start date: July 2014
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: University Hospital of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, researchers will show to caregivers of patients how to use a tDCS device (this device was designed to be easy to use, with fixed parameters and only one button to press to run the stimulation). They will be asked to apply a stimulation every day, 5 days per week during for 4 weeks, in chronic patients in minimally conscious state (MCS).

2 sessions of 4 weeks of stimulations will be realized, one anodal and one sham in a randomized order. Before and after each session, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done 8 weeks after the end of the sessions to assess the long term effect of tDCS.

Description:

A single session of tDCS showed positive effects on patients in MCS (study published in Neurology, 2014). Nevertheless, the effects went down after 1 or 2 hours. In a second study (Protocol ID: 2009/201/B) we have found that 5 days of tDCS increase the lasting of the effects up to one week.

To know if tDCS could be use in clinical daily practice, a new study will evaluate the effects of 20 minutes of tDCS over the left prefrontal dorsolateral cortex for 4 weeks, 5 days per week, in chronic patients in MCS.

2 sessions of 4 weeks of stimulation (total=20 stimulations per session) will be performed, one session will be real (anodal stimulation) and one placebo (sham stimulation).

Firstly, the patient will be seen at the hospital for a behavioral assessment (CRS-R) with one of his/her caregiver. The investigator will explain to the caregiver how to perform the stimulation. In addition, he/she will receive a folder and a video. The caregiver will take an exam to be sure he/she performs the tDCS properly.

Before and after each stimulation session, behavioral improvement will be assessed with the CRS-R by a trained neuropsychologist, at the hospital. A final assessment will be done 8 weeks after the end of the session to assess the long term effect of tDCS.

The compliance will be recorded by the deice to be sure that the caregiver performs the stimulation every day as expected.

Researchers expect to see (a) an improvement of the CRS-R total score at the end of the anodal session and (b) this improvement persists for 8 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

• be in an minimally conscious state

• be chronic (more then 3 months post insult)

• stable condition

Exclusion Criteria:

• NMDA receptor inhibitor drugs

• modification of the treatment during the protocol

• illness or infection during the protocol

• pacemaker

• metallic cerebral implant

• prior neurological disorder

• tDCS or other non-invasive brain stimulation treatment less than 3months before the inclusion in the present study

Related Conditions & MeSH terms

• Brain Injuries
• Consciousness Disorders
• Disease
• Disorders of Consciousness
• Post-comatose Non-communicative Patients
• Severe Brain Injury

Intervention

Device:
• transcranial direct current stimulation
anodal transcranial direct current stimulation on the left dorsolateral prefrontal cortex for the anodal session and sham stimulation (5secondes of tDCS) for the sham session

Locations

Country	Name	City	State
Belgium	University Hospital of Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Thibaut A, Bruno MA, Ledoux D, Demertzi A, Laureys S. tDCS in patients with disorders of consciousness: sham-controlled randomized double-blind study. Neurology. 2014 Apr 1;82(13):1112-8. doi: 10.1212/WNL.0000000000000260. Epub 2014 Feb 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the CRS-R total score	Improvement of the CRS-R total score after the end of the anodal session and 8 weeks later but no change for the sham session.	after each stimulation sessions (4 weeks) and 8 weeks later
Primary	Safety of the device (adverse effect)	a questionnaire will be asked to the caregivers and family of the patient to know any adverse effect (drowsiness, redness of the skin, epileptic sizure, sign of pain or discomfort).	Recorded after each stimulations sessions (4 weeks) and 8 weeks later
Primary	Usability of the device in daily clinical practice (compliance of the device by the caregivers)	The tDCS device records the number of stimulations performed during the protocol. We will be able to evaluate the compliance of the device by the caregivers to know if they use it properly and as expected.	After the end of the protocol (24 weeks)