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

Not Applicable
Recruiting
Conditions
Ischemic Stroke
Cognitive Impairment
Interventions
Device: sham tDCS
Device: tDCS
Behavioral: Cognitive Therapy
Registration Number
NCT04897334
Lead Sponsor
University of Pennsylvania
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
70
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
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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Sham Transcranial Direct Current Stimulation (tDCS) + cognitive therapysham tDCSParticipants 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.
Transcranial Direct Current Stimulation (tDCS) + cognitive therapytDCSParticipants 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.
Transcranial Direct Current Stimulation (tDCS) + cognitive therapyCognitive TherapyParticipants 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.
Sham Transcranial Direct Current Stimulation (tDCS) + cognitive therapyCognitive TherapyParticipants 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.
Primary Outcome Measures
NameTimeMethod
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)Baseline assessment prior to intervention; immediate post-intervention; 12 weeks (+/- 4 weeks) post-intervention; 12 months (+/- 4 weeks) post-intervention

This psychometric test covers multiple domains of cognition, comes in multiple versions to avoid practice effect, is validated in the brain injury population and can be administered in 20-30 minutes. Possible scores on the RBANS range from 40 to 160 where a higher score indicates a better outcome.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Penn Medicine Rehabilitation

🇺🇸

Philadelphia, Pennsylvania, United States

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