Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke (TRAINS)

University of Pennsylvania

Status: Enrolling

Conditions: Ischemic Stroke; Cognitive Impairment

Treatments: Behavioral: Cognitive Therapy; Device: tDCS; Device: sham tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT04897334

848469

Details and patient eligibility

About

The purpose of this study is to determine whether a non-invasive brain stimulation technique, transcranial direct current stimulation (tDCS), combined with traditional cognitive therapy will improve cognitive function in patients with subacute stroke.

Full description

This is a double-blind, sham-controlled study in which subjects with cognitive impairment after stroke will undergo neuropsychological testing before and after receiving 5 semi-consecutive daily sessions of real or sham transcranial direct current stimulation (tDCS) paired with cognitive therapy. Subjects will have experienced a stroke within 3 months of enrollment and will be undergoing inpatient rehabilitation at Penn Institute for Rehabilitation Medicine. Neuropsychological testing will be repeated immediately after completion of stimulation and 3-, 12- and 24- months following completion of treatment. The investigators will examine changes in cognitive performance induced by tDCS + cognitive therapy compared to sham tDCS + cognitive therapy. This study will combine knowledge gained from our behavioral, clinical and sociodemographic data in order to determine the relative degrees to which these properties predict whether persons with post-stroke cognitive impairment will respond to intervention.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Stroke that occurred within 4 weeks of the study
• Presence of cognitive impairment attributable to stroke
• Between the ages of 18 and 90
• Able to understand the nature of the study and give informed consent
• Able to follow simple commands as evidenced by NIHSS subtest 1C =0

Exclusion Criteria

• History of chronic, serious, or unstable neurologic illness other than stroke
• Current unstable medical illness(es)
• History of reoccurring seizures or epilepsy
• Current abuse of alcohol or drugs (prescription or otherwise)
• Active and severe psychiatric disorder
• Metallic objects in the face or head other than dental apparatus such as braces, fillings, and implants.
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

Transcranial Direct Current Stimulation (tDCS) + cognitive therapy

Active Comparator group

Description:

Participants will undergo 5 daily sessions of tDCS for 20 minutes using a montage in which an anode (2 mA) is placed over left dorsolateral prefrontal cortex and the cathode will be place on the right supraorbital area. Subjects will participate in cognitive therapy during stimulation.

Treatment:

Device: tDCS

Behavioral: Cognitive Therapy

Sham Transcranial Direct Current Stimulation (tDCS) + cognitive therapy

Sham Comparator group

Description:

Participants will undergo 5 daily sessions of sham tDCS for 20 minutes using a montage in which an anode (2 mA) is placed over left dorsolateral prefrontal cortex and the cathode will be place on the right supraorbital area. Subjects will participate in cognitive therapy during stimulation.

Treatment:

Device: sham tDCS

Behavioral: Cognitive Therapy