NCT06516588 · University of Oklahoma
tDCS for Post-Stroke Cognitive Impairment
What this study is about
This study will evaluate the effects of a form of non-invasive brain stimulation on brain functioning and memory in participants with post-stroke cognitive impairment (PSCI).
View original scientific description
This study will evaluate the effects of a form of non-invasive brain stimulation on brain functioning and memory in participants with post-stroke cognitive impairment (PSCI).
Interventions
DEVICE
Transcranial Dirrect Current Stimulation
tDCS will deliver direct current through rubber electrodes in saline-soaked sponges. Device sends a low-level current from the positive electrode, the anode, to the negative electrode, the cathode. Direct current will be transferred by a saline-soaked pair of surface sponge electrodes (35cm2) and delivered by a specially developed, battery-driven, constant current stimulator with a maximum output of 10mA. The anode will be placed over the LDLPFC and the cathode over the contralateral supra-orbital area.
Primary outcome measures
Montreal Cognitive Assessment (MoCA)
Time frame: Changes from baseline after intervention week (two weeks), one and three months
It is a 30-point test about several cognitive domains (visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation) and a screening tool used of MCI and dementia.
NIH Toolbox
Time frame: Changes from baseline after one and three months
NIH Toolbox tests is a computarize test that acess fluid abilities (i.e., working memory, processing speed, episodic memory, and two aspects of executive functioning) and crystallized abilities (i.e., dependent upon past learning and experience), resulting in Standard Scores for these superordinate categories, as well as a total Composite score of all tests.These norms were previously reported to align with the age-corrected normative data for the traditional neuropsychological measures.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 1\) ischemic stroke participants in sub-acute phase (at least 10 days after stroke event or discharge and under 5 months post-event) with cognitive dysfunction (MoCA \<26);
Exclusion criteria
- clinically significant or unstable medical or psychiatric condition;
- diagnosis of severe depression;
- history of relevant neurological diagnosis (e.g., epilepsy);
- previous neurosurgical procedure with craniectomy;
- contraindications to tDCS (implanted brain medical devices);
- severe visual impairment, hearing impairment, aphasia, neglect or dementia.
Where
- Oklahoma City, Oklahoma
Collaborators
American Heart Association
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 10, 2024 · Source of record for eligibility and locations