Recruiting

TDCs & Rehabilitation

Sponsor:

University of Pennsylvania

Code:

NCT04897334

Conditions

Ischemic Stroke

Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

tDCS

sham tDCS

Cognitive Therapy

Study Details

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.

Conditions

Ischemic Stroke

Cognitive Impairment

Study ID

NCT04897334

Start date

Sep 21, 2021

Status verified date

Jan, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Transcranial Direct Current Stimulation (tDCS) + cognitive therapy

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.

sham comparator: Sham Transcranial Direct Current Stimulation (tDCS) + cognitive therapy

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.

Interventions

tDCS

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

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

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 outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Daniela Sacchetti, MS

215-572-8485danielas@pennmedicine.upenn.edu

Kelly Sloane, MD

kelly.sloane@pennmedicine.upenn.edu

Locations

Penn Medicine Rehabilitation

Recruiting

Philadelphia, Pennsylvania, United States, 19146

More Information

Sponsor

University of Pennsylvania

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Keywords

  • post-stroke cognitive impairment
  • transcranial direct current stimulation
  • neurorehabiliation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-01-09.