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NCT Number: NCT04897334

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

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Nervous System Diseases Neurocognitive Disorders Stroke Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn Medicine Rehabilitation

Philadelphia, Pennsylvania, 19146, United States

Location status: Recruiting

Location contact

Kelli Williams, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS

Device

tDCS is a type of non-invasive brain stimulation in which small electrical currents are applied to the scalp via 2 electrodes. During sham stimulation, the current, 2 mA, will be delivered for a short amount of time and then turn-off. To deliver the current, electrodes that are placed in saline soaked sponges. They will be attached to the left side of your head; they will be held in place with an elastic cap. For both real and sham stimulation the electrodes will be placed on the scalp. Most people cannot tell the difference between real and sham stimulation.

Sham tDCS

Device

tDCS is a type of non-invasive brain stimulation in which small electrical currents are applied to the scalp via 2 electrodes. During sham stimulation, the current, 2 mA, will be delivered for a short amount of time and then turn-off. To deliver the current, electrodes that are placed in saline soaked sponges. They will be attached to the left side of your head; they will be held in place with an elastic cap. For both real and sham stimulation the electrodes will be placed on the scalp. Most people cannot tell the difference between real and sham stimulation.

cognitive therapy

Behavioral

During both the treatment and the sham intervention, participants will undero cognitive therapy training by performing the NBack task. In this sequential letter memory exercise participants are presented with sequential stimuli in the form of a series of letters. For each new stimulus they are asked to indicate if the current stimulus matches the stimulus from 2 trials prior. This exercise stimulates cognitive demand in working memory, executive function and attention and is correlated with dorsolateral prefrontal cortex activity.

Primary outcomes

  1. Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniela Sacchetti, MS

CONTACT

[email protected]

215-572-8485

Kelly Sloane, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study 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.

Acronym: TRAINS

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
May 21, 2021
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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