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Chronic StrokeNCT05248178

tDCS and Metacognitive Strategy Training in Stroke

A study testing CO-OP Procedures, tDCS and Computer Cognitive Training Procedures in people with Chronic Stroke, run by University of Missouri-Columbia at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Specific Aim 1: Complete pilot testing of study protocol in individuals with chronic stroke for feasibility evaluation and protocol refinement. Specific Aim 2: Estimate the preliminary effect of CO-OP+tDCS on activity performance in individuals with chronic stroke. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Chronic Stroke
What is being tested?
CO-OP Procedures, tDCS and Computer Cognitive Training Procedures
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
11 participants
Where
1 siteUnited States
Study dates
31 Jan 2022to 11 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >6 months post-ischemic stroke
  • not currently receiving therapy services
  • a minimum of four self-identified functional goals

Who cannot join

  • severe depressive symptoms (>20 on Patient Health Questionnaire)
  • dementia symptoms (<24 on Montreal Cognitive Assessment)
  • any additional neurological disorders
  • moderate-severe aphasia (NIH Stroke Scale aphasia scale of greater than or equal to 2)
  • any tDCS contraindication

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Missouri Occupational Therapy Department

    Columbia, Missouri, 65203

Other trials in United States

About this study

Official title: Pilot Testing of tDCS and Metacognitive Strategy Training in Chronic Stroke

Specific Aim 1: Complete pilot testing of study protocol in individuals with chronic stroke for feasibility evaluation and protocol refinement. Specific Aim 2: Estimate the preliminary effect of CO-OP+tDCS on activity performance in individuals with chronic stroke.

Read the detailed description

A number of daily life activities are discontinued after stroke. These discontinued activities typically include basic self-care, instrumental activities of daily living, leisure, and work. These changes in participation contribute to decreased quality of life and life satisfaction. The Cognitive Orientation to daily Occupational Performance (CO-OP) approach is a behavioral problem-solving intervention that focuses on teaching clients how to apply cognitive strategies to enhance learning and overcome activity performance barriers.

CO-OP uses meaningful, client-chosen activities to drive new skill learning and neural reorganization. Consistent with these principles of neuroplasticity, transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method of modulating cortical excitability through application of low currents to targeted regions on the scalp.

There are known positive effects of CO-OP to improve activity performance and for tDCS to improve impairment level outcomes post-stroke. The investigators hypothesize that the known effects of CO-OP may be amplified with use of tDCS to alter known neural hubs of executive networks that support problem-solving. In sum, (1) CO-OP is effective at improving activity performance, and (2) the effects of CO-OP may be amplified through novel methods that allow for placing the brain in an enhanced neuroplastic state, such as tDCS.

Conditions
Chronic Stroke
Being tested
CO-OP Procedures, tDCS, Computer Cognitive Training Procedures, sham tDCS group
Keywords
Stroke, Metacognitive Strategy Training, Brain Stimulation, CO-OP, tDCS
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CO-OP ProceduresBehavioural

    CO-OP focuses on learning of a global problem-solving strategy, Goal-Plan-Do-Check (GPDC), within the performance of participant-chosen goals. Use of a broadly applicable strategy and meaningful activity ensures the intervention is salient to the participant and increases likelihood of transfer. Uniquely, therapists applying CO-OP use guided discovery methods to support participants in analyzing their own performance of a given task and generating potential solutions for improving performance. Participants become equipped with these skills through repetitive application of the Goal-Plan-Do-Check process.The intervention focuses on learning GPDC with gradual withdrawal of guided discovery methods.

  • tDCSDevice

    Each session will begin with 20 minutes of anodal tDCS applied to the ipsilesional dorsolateral prefrontal cortex (DLPFC) at 1.5 mA. The cathode will be placed over the contralesional supraorbital area. Direct current will be applied through two saline soaked sponges placed on the scalp. The tDCS device contains software for double-blinded delivery.

  • Computer Cognitive Training ProceduresBehavioural

    Individuals receiving computerized cognitive training will receive an equal dosage of 12, 45-minute sessions directly following the assigned tDCS condition. The online training software of BrainHQ will be used. BrainHQ is a well-recognized cognitive training program that targets the areas of attention, memory, processing speed, people skills, intelligence, and navigation. BrainHQ tracks progress and automatically grades difficulty as appropriate.

  • sham tDCS groupDevice

    Sham tDCS will involve the same preparation as in tDCS, but the current will ramp up for only 30 seconds and then return to zero. This method allows for sensations on the scalp associated with tDCS without inducing any neural changes.

Study groups in NCT05248178
Study groupRoleWhat they receive
CO-OP and tDCS groupExperimentalEach 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.
Receives: Behavioral: CO-OP Procedures; Device: tDCS
CO-OP and sham tDCS groupActive comparatorEach session will consist 20 minutes of sham tDCS followed by 45 minutes of the assigned CO-OP.
Receives: Behavioral: CO-OP Procedures; Device: sham tDCS group
Computer cognitive training and tDCS groupActive comparatorEach 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.
Receives: Device: tDCS; Behavioral: Computer Cognitive Training Procedures
Computer cognitive training and sham tDCS groupActive comparatorEach session will consist 20 minutes of sham tDCS followed by 45 minutes of the assigned computer cognitive training.
Receives: Behavioral: Computer Cognitive Training Procedures; Device: sham tDCS group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Willingness to be randomized

    Percent of eligible participants willing to be randomized

    Measured: After study completion, an average of 5 weeks

  2. Recruitment

    Number enrolled/number screened AND number recruited per month

    Measured: After study completion, an average of 5 weeks

  3. Retention

    Number completing study procedures/number enrolled

    Measured: After study completion, an average of 5 weeks

  4. Adherence

    Number of sessions attended/total number of sessions

    Measured: After study completion, an average of 5 weeks

Secondary outcomes (6)
  1. Canadian Occupational Performance Measure

    Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.

    Measured: Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)

  2. Performance Quality Rating Scale

    Objective measure activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.

    Measured: Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)

  3. National Institutes of Health Toolbox Cognition Battery

    Computerized measure of cognitive precesses (e.g. executive function, attention, working memory.) A crystalized intelligence composite T-score and fluid intelligence T-score with means of 100 and a standard deviation of 15 will be used in analysis. Higher scores represent better performance.

    Measured: Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)

  4. Weekly Calendar Planning Assessment

    Performance-based measure of executive function within a simulated calendar planning task. Level II will be used. Total appointments entered correctly and an efficiency score will be used in analysis. Higher scores represent better performance.

    Measured: Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)

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

    Self-report measure of confidence in performing daily activities. It consists of 35 items in six domains. Each item is rated on a scale of 1 to 10 with higher scores representing greater self-efficacy.

    Measured: Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)

  6. Stroke Impact Scale (SIS) - Participation domain

    Self-report measure of participation in daily life activities. The participation domain consists of 8 items with resulting scores from 0 to 100 and higher scores representing higher levels of participation.

    Measured: Pre-intervention (week 0), post-intervention (week 5), 1-month follow up (week 9)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2022
  2. Study start31 Jan 2022
  3. Primary completion11 Jun 2025
  4. Study completion11 Jun 2025

Why it stopped: Recruitment halted due to recruitment difficulties.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05248178
Sponsor's protocol ID
2076763
Status last verified
Jun 2025
First submitted
9 Feb 2022
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Hartman-Maeir A, Soroker N, Ring H, Avni N, Katz N. Activities, participation and satisfaction one-year post stroke. Disabil Rehabil. 2007 Apr 15;29(7):559-66. doi: 10.1080/09638280600924996.

    PubMed 17453976
  • Mayo NE, Wood-Dauphinee S, Cote R, Durcan L, Carlton J. Activity, participation, and quality of life 6 months poststroke. Arch Phys Med Rehabil. 2002 Aug;83(8):1035-42. doi: 10.1053/apmr.2002.33984.

    PubMed 12161823
  • McEwen S, Polatajko H, Baum C, Rios J, Cirone D, Doherty M, Wolf T. Combined Cognitive-Strategy and Task-Specific Training Improve Transfer to Untrained Activities in Subacute Stroke: An Exploratory Randomized Controlled Trial. Neurorehabil Neural Repair. 2015 Jul;29(6):526-36. doi: 10.1177/1545968314558602. Epub 2014 Nov 21.

    PubMed 25416738
  • Henshaw E, Polatajko H, McEwen S, Ryan JD, Baum CM. Cognitive approach to improving participation after stroke: two case studies. Am J Occup Ther. 2011 Jan-Feb;65(1):55-63. doi: 10.5014/ajot.2011.09010.

    PubMed 21309372
  • Polatajko HJ, McEwen SE, Ryan JD, Baum CM. Pilot randomized controlled trial investigating cognitive strategy use to improve goal performance after stroke. Am J Occup Ther. 2012 Jan-Feb;66(1):104-9. doi: 10.5014/ajot.2012.001784.

    PubMed 22389945
  • Kandel M, Beis JM, Le Chapelain L, Guesdon H, Paysant J. Non-invasive cerebral stimulation for the upper limb rehabilitation after stroke: a review. Ann Phys Rehabil Med. 2012 Dec;55(9-10):657-80. doi: 10.1016/j.rehab.2012.09.001. Epub 2012 Sep 29. English, French.

    PubMed 23084320
  • Kang N, Summers JJ, Cauraugh JH. Transcranial direct current stimulation facilitates motor learning post-stroke: a systematic review and meta-analysis. J Neurol Neurosurg Psychiatry. 2016 Apr;87(4):345-55. doi: 10.1136/jnnp-2015-311242. Epub 2015 Aug 28.

    PubMed 26319437
  • Park SH, Koh EJ, Choi HY, Ko MH. A double-blind, sham-controlled, pilot study to assess the effects of the concomitant use of transcranial direct current stimulation with the computer assisted cognitive rehabilitation to the prefrontal cortex on cognitive functions in patients with stroke. J Korean Neurosurg Soc. 2013 Dec;54(6):484-8. doi: 10.3340/jkns.2013.54.6.484. Epub 2013 Dec 31.

    PubMed 24527190
  • French B, Thomas L, Leathley M, Sutton C, McAdam J, Forster A, Langhorne P, Price C, Walker A, Watkins C. Does repetitive task training improve functional activity after stroke? A Cochrane systematic review and meta-analysis. J Rehabil Med. 2010 Jan;42(1):9-14. doi: 10.2340/16501977-0473.

    PubMed 20111838
  • French B, Thomas LH, Leathley MJ, Sutton CJ, McAdam J, Forster A, Langhorne P, Price CI, Walker A, Watkins CL. Repetitive task training for improving functional ability after stroke. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006073. doi: 10.1002/14651858.CD006073.pub2.

    PubMed 17943883
  • Lang CE, Strube MJ, Bland MD, Waddell KJ, Cherry-Allen KM, Nudo RJ, Dromerick AW, Birkenmeier RL. Dose response of task-specific upper limb training in people at least 6 months poststroke: A phase II, single-blind, randomized, controlled trial. Ann Neurol. 2016 Sep;80(3):342-54. doi: 10.1002/ana.24734. Epub 2016 Aug 16.

    PubMed 27447365
  • Tedesco Triccas L, Burridge JH, Hughes AM, Pickering RM, Desikan M, Rothwell JC, Verheyden G. Multiple sessions of transcranial direct current stimulation and upper extremity rehabilitation in stroke: A review and meta-analysis. Clin Neurophysiol. 2016 Jan;127(1):946-955. doi: 10.1016/j.clinph.2015.04.067. Epub 2015 May 4.

    PubMed 25998205
  • Van Peppen RP, Kwakkel G, Wood-Dauphinee S, Hendriks HJ, Van der Wees PJ, Dekker J. The impact of physical therapy on functional outcomes after stroke: what's the evidence? Clin Rehabil. 2004 Dec;18(8):833-62. doi: 10.1191/0269215504cr843oa.

    PubMed 15609840
  • Appelros P, Samuelsson M, Karlsson-Tivenius S, Lokander M, Terent A. A national stroke quality register: 12 years experience from a participating hospital. Eur J Neurol. 2007 Aug;14(8):890-4. doi: 10.1111/j.1468-1331.2007.01826.x.

    PubMed 17662010
  • Desrosiers J, Noreau L, Rochette A, Bourbonnais D, Bravo G, Bourget A. Predictors of long-term participation after stroke. Disabil Rehabil. 2006 Feb 28;28(4):221-30. doi: 10.1080/09638280500158372.

    PubMed 16467057

Questions about this trial

What is this clinical trial studying?

A study testing CO-OP Procedures, tDCS and Computer Cognitive Training Procedures in people with Chronic Stroke, run by University of Missouri-Columbia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Recruitment halted due to recruitment difficulties.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Willingness to be randomized (time frame: After study completion, an average of 5 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05248178, which also lists 52 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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