tDCS in Patients With Disorder of Consciousness Due to Severe Acquired Brain Injury

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03367078
• Date of registration: 04/12/2017
• Prospective Registration: Yes
• Primary sponsor: Montecatone Rehabilitation Institute S.p.A.
• Public title: tDCS in Patients With Disorder of Consciousness Due to Severe Acquired Brain Injury
• Scientific title: Observational Study on the Use of Transcranial Direct Stimulation in Patients With Disorder of Consciousness, Due to Severe Acquired Brain Injury, to Stimulate Recovery of Consciousness
• Date of first enrolment: June 18, 2018
• Target sample size: 1
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03367078
• Study type: Observational

Countries of recruitment

Italy

Contacts

• Name: Angela Morreale, MD
• Affiliation: Montecatone Rehabilitation Institute S.p.A.

Key inclusion & exclusion criteria

Inclusion Criteria:

- patients with Disorder of Consciousness, VS (= LCF 2) or MCS (= LCF 3), due to sABI;

- any etiology, with the exception of extensive haemorrhagic lesions;

- stable clinical conditions.

Exclusion Criteria:

- presence of implanted devices (e.g. pacemakers, intrathecal infusers);

- presence of metallic brain implants (clips) or intracranial implants;

- presence of extensive craniotomy involving the area of application of tDCS;

- history of epileptic seizure;

- mechanical ventilation in place;

- history of psychotic disorders;

- severe neurodegenerative pathology;

- pharmacotherapy with Na+ or Ca++ channel blockers (e.g. Carbamazepine) or with
N-Methyl-D-aspartate (NMDA) receptor antagonists (e.g. Dextromethorphan);

- pregnancy in progress.



Age minimum: 16 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cognitive Impairment

Minimally Conscious State

Consciousness Disorders

Brain Injuries

Vegetative State

Intervention(s)

Other: Usual care

Device: Anodal tDCS

Primary Outcome(s)

Change in cognitive functioning level in the tDCS cohort (short- and mid-term outcomes) [Time Frame: Baseline (initial visit); tDCS session 5 (1 week); tDCS closing session 10 (2 weeks); follow-up 1 (1 week after tDCS closing session 10); follow-up 2 (3 months after tDCS closing session 10)]

Change in coma recovery in the tDCS cohort (short- and mid-term outcomes) [Time Frame: Baseline (initial visit); tDCS session 5 (1 week); tDCS closing session 10 (2 weeks); follow-up 1 (1 week after tDCS closing session 10); follow-up 2 (3 months after tDCS closing session 10)]

Secondary Outcome(s)

Change in disability level in the tDCS cohort (short-, mid- and long-term follow-up) [Time Frame: Baseline (initial visit); follow-up 1 (1 week after tDCS closing session 10); follow-up 2 (3 months after tDCS closing session 10); follow-up 3 (6 months after closing session 10)]

Change in coma recovery between the tDCS cohort and the Historical control cohort [Time Frame: Baseline (initial visit); 3 months; 6 months]

Change in electroencephalography pattern in the tDCS cohort [Time Frame: Baseline (initial visit); tDCS tDCS closing session 10 (2 weeks)]

Change in coma recovery in the tDCS cohort (long-term outcome) [Time Frame: Baseline (initial visit); follow-up 3 (6 months after tDCS closing session 10)]

Change in disability level between the tDCS cohort and the Historical control cohort [Time Frame: Baseline (initial visit); 3 months; 6 months]

Change in cognitive functioning level in the tDCS cohort (long-term outcome) [Time Frame: Baseline (initial visit); follow-up 3 (6 months after tDCS closing session 10)]

Change in cognitive functioning level between the tDCS cohort and the Historical control cohort [Time Frame: Baseline (initial visit); 3 months; 6 months]

Secondary ID(s)

CE-17101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors