Clinical trial NCT04897334: Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke
Official title: Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke (TRAINS): Neuromodulatory Intervention to Ameliorate Cognition After Stroke for Individuals At Risk for VCID.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Cognitive Impairment
Keywords: post-stroke cognitive impairment
transcranial direct current stimulation
neurorehabiliation
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: Baseline assessment prior to intervention; immediate post-intervention; 12 weeks (+/- 4 weeks) post-intervention; 12 months (+/- 4 weeks) post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine Rehabilitation
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kelly Sloane, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Roy Hamilton, MD
role: PRINCIPAL_INVESTIGATOR
References: