Using brain stimulation and therapy to improve thinking skills after stroke
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.
This study is testing if combining brain stimulation with therapy can help improve thinking skills in people who have had a stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04897334 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) combined with cognitive therapy in enhancing cognitive function in patients who have experienced a subacute ischemic stroke. Participants will undergo a double-blind, sham-controlled intervention consisting of five daily sessions of either real or sham tDCS alongside cognitive therapy. Neuropsychological assessments will be conducted before and after the intervention, as well as at 3, 12, and 24 months post-treatment, to measure changes in cognitive performance. The study will also analyze various factors to predict which patients are most likely to benefit from the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 who have experienced a stroke within the last four weeks and exhibit cognitive impairment.
Not a fit: Patients with chronic neurological conditions, severe psychiatric disorders, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve cognitive function in stroke survivors, enhancing their quality of life and rehabilitation outcomes.
How similar studies have performed: Other studies have shown promising results using tDCS for cognitive rehabilitation, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Philadelphia, Pennsylvania
- Penn Medicine Rehabilitation — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Kelly Sloane, MD — University of Pennsylvania
- Study coordinator: Daniela Sacchetti, MS
- Email: danielas@pennmedicine.upenn.edu
- Phone: 215-572-8485
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.