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

NCT03367078 | Terminated

• 1 other identifier: CE-17101
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The present observational study is aimed at reporting the short-, mid- and long-term outcomes of patients with Disorder of Consciousness (DOC), in Vegetative State (VS) or Minimally Conscious State (MCS), due to a severe Acquired Brain Injury (sABI), after repeated treatments with anodal Transcranial Direct Current Stimulation (tDCS) on Left Dorsolateral Prefrontal Cortex (L-DLPFC), to stimulate recovery of consciousness. The results obtained will also be compared with those of a historical control cohort, before the introduction of tDCS, matched for demographic and clinical characteristics.

Conditions

Consciousness Disorders; Brain Injuries; Vegetative State; Minimally Conscious State; Cognitive Impairment

Keywords

tDCS; transcranial direct current stimulation; acquired brain injury; coma; vigilance

Outcome Measures

Primary Outcomes (2)

• Change in coma recovery in the tDCS cohort (short- and mid-term outcomes)

  Assessment by Coma Recovery Scale-Revised (CRS-R) (on-line, where tDCS is administered)

  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 cognitive functioning level in the tDCS cohort (short- and mid-term outcomes)

  Assessment by Levels of Cognitive Functioning Scale (LCF) (off-line, i.e. where tDCS is administered, immediately after tDCS session)

  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 Outcomes (7)

• Change in coma recovery in the tDCS cohort (long-term outcome)

  Baseline (initial visit); follow-up 3 (6 months after tDCS closing session 10)

• Change in cognitive functioning level in the tDCS cohort (long-term outcome)

  Baseline (initial visit); follow-up 3 (6 months after tDCS closing session 10)

• Change in disability level in the tDCS cohort (short-, mid- and long-term follow-up)

  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 electroencephalography pattern in the tDCS cohort

  Baseline (initial visit); tDCS tDCS closing session 10 (2 weeks)

• Change in coma recovery between the tDCS cohort and the Historical control cohort

  Baseline (initial visit); 3 months; 6 months

Study Arms (2)

tDCS cohort

DOC patients treated according to usual care, plus anodal tDCS (prospective cohort)

Device: Anodal tDCS; Other: Usual care

Historical control cohort

DOC patients treated according to usual care only (retrospective cohort of patients matched for demographic and clinical characteristics, admitted at the Montecatone Rehabilitation Institute no more than 3 years before the introduction of tDCS)

Other: Usual care

Interventions

Anodal tDCS DEVICE

Anodal tDCS, on L-DLPFC area, is started 2 weeks after admission to the sABI Operative Unit with: one session per day (in the morning), possibly for 5 consecutive days per week (from Monday to Friday), for 2 consecutive weeks. Each tDCS session lasts 20 minutes. Current intensity is 1 mA during the first week, 2 mA in the second week

tDCS cohort

Usual care OTHER

Usual care of DOC patients

Historical control cohort; tDCS cohort

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive DOC patients admitted to the sABI Operative Unit of the Montecatone Rehabilitation Institute

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montecatone Rehabilitation Institute S.p.A.: lead

Study Sites (1)

Montecatone Rehabilitation Institute S.p.A.

Imola, BO, 40026, Italy

Location

MeSH Terms

Conditions

Consciousness Disorders; Brain Injuries; Persistent Vegetative State; Cognitive Dysfunction; Coma

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Damage, Chronic; Unconsciousness; Cognition Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Angela Morreale, MD

  Montecatone Rehabilitation Institute S.p.A.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 8, 2017
• Study Start: June 18, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: August 14, 2020

Record last verified: 2020-08

Locations

IT (1)