Neurostimulation for Cognitive Rehabilitation in Stroke (NeuroCog)

Federal University of Paraíba

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Cerebral Infarction; Cognitive Impairment; Stroke

Treatments: Device: transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02315807

NeuroCog001

Details and patient eligibility

About

Transcranial direct current stimulation has shown promising results in stroke patients. This study is a double blind, sham-controlled clinical trial aiming to compare the long-term effects of stimulation in two different cognitive regions after a stroke. Sixty patients who suffer from chronic strokes will be randomized into 1 of 3 groups: dorsolateral prefrontal cortex, cingulo-opercular network and motor primary cortex (control). Each group will receive transcranial direct current stimulation for 20 minutes for 10 consecutive working days (2 weeks). Patients will be assessed with a Dysexecutive Questionnaire, Semantic Fluency test, categorical verbal fluency and Go-no go tests, Wechsler Adult Intelligence Scale, Rey Auditory-Verbal Learning Test, Letter Comparison and Pattern Comparison Tasks at baseline, after their tenth stimulation session (week 2) and endpoint (week 4). Those who achieve clinical improvement with neurostimulation will be invited to receive treatment for 12 months as part of a follow-up study.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ischaemic chronic stroke
• Mild/Moderate Cognitive impairment
• Informed consent

Exclusion criteria

• National Institute of Health Stroke Scale (NIHSS) ≥ 16 points
• Severe cognitive comorbidities (dementia, depression)
• transcranial direct current stimulation criteria: use of modulators of the Central Nervous System drugs; patients with implanted metallic or electronic devices; pacemaker; seizures; pregnancy;any other condition that might limit or interfere in the sensorimotor system

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups

dlPFC

Experimental group

Description:

Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in dorsolateral prefrontal cortex

Treatment:

Device: transcranial direct current stimulation

CON

Experimental group

Description:

Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in cingulo-opercular network

Treatment:

Device: transcranial direct current stimulation

M1

Active Comparator group

Description:

Participants in the chronic post-stroke stage will receive active transcranial direct current stimulation in motor primary cortex

Treatment:

Device: transcranial direct current stimulation