What this study is
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.
What's being tested
- tDCS
Intervention · DEVICE
- sham tDCS
Intervention · DEVICE
- Cognitive Therapy
Intervention · 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.
Both tDCS and 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.
Study details
- 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.
- Sponsor
- University of Pennsylvania
- Conditions
- Ischemic Stroke · Cognitive Impairment
- Enrolling
- 70 people
- Starts
- 2021-09-21
- Est. completion
- 2028-01
- Design
- Quadruple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 90 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openPenn Medicine Rehabilitation
Philadelphia, Pennsylvania, United States
- Kelli Williams, PhD · Contact
Recruiting
Study team
Sponsor
University of Pennsylvania
Study ID 848469
Principal investigator
Kelly Sloane, MD
University of Pennsylvania
Principal investigator
Roy Hamilton, MD
University of Pennsylvania
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.