Long-term Effect of tDCS in Patients With Disorders of Consciousness

Disorder of Consciousness Clinical Trial

Official title:

Long-term Effect of 20 Sessions of Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness: a Double Blind Sham Controlled Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03114397
• Other study ID #: 2014/113b
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: December 24, 2021

Study information

• Verified date: November 2022
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this multicentric double-blind sham controlled study, the investigators plan to assess the effects of 20 sessions of tDCS on long-term behavioral recovery in patients with disorders of consciousness. Neurophysiological outcomes (EEG) will also be collected. This research will 1) determine whether long-term behavioral recovery can be promoted with tDCS and 2) generate knowledge regarding the impact of tDCS on neurophysiological outcome (i.e., EEG) in severely brain injured patients. The investigators will compare the effects of active and sham tDCS on behavioral assessments and quantitative EEG in patients with severe brain injury and its potential application in rehabilitation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 24, 2021
• Est. primary completion date: December 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

• CNS medication stable for at least a week
• Stable diagnosis (no diagnosis change based on 2 CRS-R performed within 1 week).
• Between 3 and 24 months post injury
• Structural MRI or CT-scan (to evidence focal lesions on the left DLPFC)

Exclusion Criteria:

• Craniotomies encompassing the frontal region (electrodes location)
• VPS under the stimulated area (prefrontal cortex)
• Pacemaker
• Metallic cerebral implant
• Severe medical conditions that might influence clinical diagnosis and EEG activity (e.g., severe hepatic insufficiency or renal failure, or sub-continuous or abundant epileptiform discharges on standard EEG recordings).

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorder of Consciousness

Intervention

Device:
• transcranial direct current stimulation - active
transcranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes.
• transcranial direct current stimulation - sham
transcranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes. The sham intervention consists of 30 seconds of stimulation at the beginning and the end of the 20minutes of intervention.

Locations

Country	Name	City	State
Belgium	University of Liege	Liege

Sponsors (10)

Lead Sponsor	Collaborator
University of Liege	Azienda Unita Sanitaria Locale di Piacenza, Italy, Fondazione Salvatore Maugeri, Italy, Hospitales Nisa, Spain, I.R.C.C.S. Fondazione Santa Lucia, Italy, pavlov state medical university, Russia, Research Center of Neurology, Russia, Schoen Clinic Bad Aibling, Germany, Therapiezentrum Burgau, Germany, Université Catholique de Louvain, Belgium

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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

Thibaut A, Wannez S, Donneau AF, Chatelle C, Gosseries O, Bruno MA, Laureys S. Controlled clinical trial of repeated prefrontal tDCS in patients with chronic minimally conscious state. Brain Inj. 2017;31(4):466-474. doi: 10.1080/02699052.2016.1274776. Epub 2017 Mar 10. — 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.	4 weeks