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tDCS + Cognitive Training for Stroke

N/A

Recruiting

Led By Anna E Boone, PhD, OTR/L

Research Sponsored by University of Missouri-Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

not currently receiving therapy services

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)

Awards & highlights

Study Summary

This trial is testing a new stroke rehabilitation protocol that involves tDCS stimulation. They are testing for feasibility and preliminary effectiveness.

Who is the study for?

This trial is for individuals who had an ischemic stroke at least 6 months ago, are not currently in therapy, and have at least four personal goals they want to achieve. People with severe depression, dementia symptoms, other neurological disorders, moderate to severe speech difficulties (aphasia), or any condition that makes tDCS unsafe cannot join.Check my eligibility

What is being tested?

The study tests if a combination of CO-OP (Cognitive Orientation to daily Occupational Performance) strategies and brain stimulation (tDCS) can improve the ability to perform daily activities in those who've had a stroke. Some participants will receive sham tDCS as a comparison.See study design

What are the potential side effects?

Possible side effects from tDCS may include mild discomfort or itching under the electrode during treatment. There's also a small risk of skin irritation. The CO-OP approach itself typically does not cause side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am not currently undergoing any therapy treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence

Recruitment

Retention

+1 more

Secondary outcome measures

Canadian Occupational Performance Measure

National Institutes of Health Toolbox Cognition Battery

Participation Strategies-Self-efficacy Scale (PS-SES)

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: CO-OP and tDCS groupExperimental Treatment2 Interventions

Each session will consist of 20 minutes of anodal tDCS applied to the left dorsolateral prefrontal cortex (DLPFC) at 1.5 mA. This will be followed by 45 minutes of the assigned CO-OP.

Group II: Computer cognitive training and tDCS groupActive Control2 Interventions

Each session will consist of 20 minutes of anodal tDCS applied to the left dorsolateral prefrontal cortex (DLPFC) at 1.5 mA. This will be followed by 45 minutes of the assigned computer cognitive training.

Group III: CO-OP and sham tDCS groupActive Control2 Interventions

Each session will consist 20 minutes of sham tDCS followed by 45 minutes of the assigned CO-OP.

Group IV: Computer cognitive training and sham tDCS groupActive Control2 Interventions

Each session will consist 20 minutes of sham tDCS followed by 45 minutes of the assigned computer cognitive training.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

tDCS

2017

Completed Phase 2

~640

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor

361 Previous Clinical Trials

627,966 Total Patients Enrolled

7 Trials studying Stroke

401 Patients Enrolled for Stroke

Anna E Boone, PhD, OTR/LPrincipal InvestigatorUniversity of Missouri Occupational Therapy

2 Previous Clinical Trials

109 Total Patients Enrolled

Media Library

CO-OP Procedures Clinical Trial Eligibility Overview. Trial Name: NCT05248178 — N/A

Stroke Research Study Groups: CO-OP and tDCS group, Computer cognitive training and tDCS group, CO-OP and sham tDCS group, Computer cognitive training and sham tDCS group

Stroke Clinical Trial 2023: CO-OP Procedures Highlights & Side Effects. Trial Name: NCT05248178 — N/A

CO-OP Procedures 2023 Treatment Timeline for Medical Study. Trial Name: NCT05248178 — N/A

Stroke Patient Testimony for trial: Trial Name: NCT05248178 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research permit participants aged 85 and up to participate?

"As per regulations, the minimum age for enrolment into this clinical trial is 18 while those at 85 years old are barred from taking part."

Answered by AI

Is enrollment open for this research endeavor?

"Currently, according to information featured on clinicaltrials.gov, this medical study is enrolling patients. The trial was initially posted on January 31st 2022 and has been recently modified in March 14th 2022."

Answered by AI

What is the cap for participants in this clinical trial?

"Affirmative. Perusal of clinicaltrials.gov reveals that this investigation is recruiting patients, with the original posting date being January 31st 2022 and the most recent edit occurring on March 14th 2022. A total of 28 participants must be enlisted from 1 location."

Answered by AI

What type of individuals would be ideal participants in this research?

"This research trial has 28 openings for individuals aged 18 to 85 who are living with chronic stroke. To qualify, these persons must be at least 6 months post-ischemic stroke, not engaging in therapy services currently and have a minimum of four self-defined goals related to their functioning."

Answered by AI

What are the hoped for results of this medical study?

"This trial's primary goal is to measure enrollee numbers after a 5 week period. Secondary assessment markers include the Stroke Impact Scale, Performance Quality Rating Scale, and NIH Toolbox Cognition Battery. The latter two are scored from 1-10 with higher scores representing better performance; whereas the SIS consists of 8 items evaluated on a 0-100 scale where higher marks denote greater participation in daily activities."

Answered by AI