NCT04897334

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Sep 2021Jan 2028

First Submitted

Initial submission to the registry

May 17, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

September 21, 2021

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

5.7 years

First QC Date

May 17, 2021

Last Update Submit

January 7, 2026

Conditions

Ischemic StrokeCognitive Impairment

Keywords

post-stroke cognitive impairmenttranscranial direct current stimulationneurorehabiliation

Outcome Measures

Primary Outcomes (1)

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

    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.

    Baseline assessment prior to intervention; immediate post-intervention; 12 weeks (+/- 4 weeks) post-intervention; 12 months (+/- 4 weeks) post-intervention

Study Arms (2)

Transcranial Direct Current Stimulation (tDCS) + cognitive therapy

ACTIVE COMPARATOR

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.

Device: tDCSBehavioral: Cognitive Therapy

Sham Transcranial Direct Current Stimulation (tDCS) + cognitive therapy

SHAM COMPARATOR

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.

Device: sham tDCSBehavioral: Cognitive Therapy

Interventions

tDCSDEVICE

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.

Transcranial Direct Current Stimulation (tDCS) + cognitive therapy
sham tDCSDEVICE

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 Transcranial Direct Current Stimulation (tDCS) + cognitive therapy
Cognitive TherapyBEHAVIORAL

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.

Sham Transcranial Direct Current Stimulation (tDCS) + cognitive therapyTranscranial Direct Current Stimulation (tDCS) + cognitive therapy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn Medicine Rehabilitation

Philadelphia, Pennsylvania, 19146, United States

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeCognitive Dysfunction

Interventions

Transcranial Direct Current StimulationCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological TechniquesBehavior TherapyPsychotherapy

Study Officials

  • Kelly Sloane, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Roy Hamilton, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Sacchetti, MS

CONTACT

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

Kelly Sloane, MD

CONTACT

kelly.sloane@pennmedicine.upenn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology

Study Record Dates

First Submitted

May 17, 2021

First Posted

May 21, 2021

Study Start

September 21, 2021

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations

US(1)