Chronic StrokePhase 1NCT04617548

tDCS and CO-OP in Chronic Stroke

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This project seeks to evaluate the acceptability feasibility, practicality feasibility, and preliminary effect of combining transcranial direct current stimulation (tDCS) and metacognitive strategy training (MCST) in individuals with chronic stroke. Read more about this study

Who is it for?: Ages 30 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Stroke
What is being tested?: tDCS and CO-OP Group
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2020to 1 Jan 2022
Phase: Phase 1
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 30 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

> 6 months post mild to moderate ischemic stroke
self-reported functional limitations
Age 30-80

Who cannot join

history of other neurological diagnoses
cognitive impairment (less than or equal to 21 on the Montreal Cognitive Assessment)
severe aphasia (greater than or equal to 2 on the NIHSS language item
non-English speaking
any additional condition where the PI deems participation unsafe
pregnancy, 7)

Show all 11Show fewer

history of seizures
medications that influence cortical excitability
metallic implants above the chest
history of welding or metalwork
severe depressive symptoms (>21 on Patient Health Questionnaire)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Missouri-Columbia
Columbia, Missouri, 652122

Other trials in United States

About this study

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

Read the detailed description

Currently seven million people are living in the United States post stroke, making stroke the leading cause of long term disability. Almost half of the people living in the community following stroke have problems that challenge the activities that support their daily lives. This is in part due to the rehabilitation community's focus on short term stroke recovery and not on supporting survivors' need to actively manage their long-term disability and the environment around them so they can return to full participation in communities of their choice post-rehabilitation. The rehabilitation community is in need of evidence-based interventions for addressing post-stroke functional limitations. Metacognitive strategy training is a performance-based, problem-solving approach to task performance difficulties. Participants are taught to identify when to apply a cognitive strategy, how to apply it, and how to monitor and adapt usage of cognitive strategies within task performance. Metacognitive strategy training is recognized as a practice standard for addressing functional limitations post-stroke. Transcranial direct current stimulation is a method that has been used for over 15 years to modulate the excitability of targeted brain regions. While it does not directly stimulate neurons, it results in changes to polarity of neuronal membranes and is thought to facilitate or inhibit neuroplasticity. Combination of these approaches may result in an interaction of effects and a greater effect on function in individuals post-stroke than either approach used alone.

Conditions: Chronic Stroke
Being tested: tDCS and CO-OP 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.

tDCS and CO-OP GroupCombination product
Also called Brain Stimulation and Metacognitive Strategy
Transcranial direct current stimulation modulates the excitability of targeted brain regions, and is thought to facilitate or inhibit neuroplasticity. Participants will receive anodal tDCS (1.5 mA) to the dorsolateral prefrontal cortex (dlPFC) for 20 minutes at the beginning of each session. 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.

Study groups in NCT04617548
Study group	Role	What they receive
tDCS and CO-OP Group	Experimental	One-hour session three times per week for 4 weeks. Participants will receive anodal tDCS (1.5 mA) to the dorsolateral prefrontal cortex (dlPFC) for 20 minutes at the beginning of each session. Following each tDCS session, the participants will complete a sensations questionnaire.The basis for each session will be task-based practice of client-chosen goals and the use of cognitive strategies using CO-OP. Receives: Combination Product: tDCS and CO-OP Group

What is being measured

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

Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), & Feasibility of Intervention Measure
A brief questionnaire to evaluate participant satisfaction regarding the intervention's acceptability, appropriateness, and feasibility
Measured: after study completion, an average of 5 weeks
Semi-Structured Interview
A brief interview to gather participant perceptions of the intervention, including their perceived benefit and practicality of the intervention and suggestions for improvement for the intervention.
Measured: after study completion, an average of 5 weeks
Client Satisfaction Questionnaire (CSQ-8)
Self-report, 8 item measures of intervention acceptability
Measured: after study completion, an average of 5 weeks

Secondary outcomes (2)

Performance Quality Rating Scale (PQRS)
An objective measure of participant performance of goals. Each goal is rated by a trained observer from 1 (no activity criteria were met) and 10 (all activity criteria were met).
Measured: Pre-intervention and post-intervention, typically an average of 5 weeks
Canadian Occupational Performance Measure (COPM)
Self-report measures of perceived performance and satisfaction of occupational performance on a 1 to 10 Likert scale
Measured: Pre-intervention and post-intervention, typically an average of 5 weeks

Timeline

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

1 Jan 20201 Jan 2022

First posted5 Nov 2020
Study start1 Jan 2020
Primary completion31 Dec 2021
Study completion1 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Chronic StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04617548
Sponsor's protocol ID: 2009451
Status last verified: Feb 2022
First submitted: 25 Sep 2020
Last updated: 11 Feb 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015.
PubMed 21440699
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
Iyer MB, Mattu U, Grafman J, Lomarev M, Sato S, Wassermann EM. Safety and cognitive effect of frontal DC brain polarization in healthy individuals. Neurology. 2005 Mar 8;64(5):872-5. doi: 10.1212/01.WNL.0000152986.07469.E9.
PubMed 15753425
Liebetanz D, Koch R, Mayenfels S, Konig F, Paulus W, Nitsche MA. Safety limits of cathodal transcranial direct current stimulation in rats. Clin Neurophysiol. 2009 Jun;120(6):1161-7. doi: 10.1016/j.clinph.2009.01.022. Epub 2009 Apr 28.
PubMed 19403329
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
Nitsche MA, Liebetanz D, Lang N, Antal A, Tergau F, Paulus W. Safety criteria for transcranial direct current stimulation (tDCS) in humans. Clin Neurophysiol. 2003 Nov;114(11):2220-2; author reply 2222-3. doi: 10.1016/s1388-2457(03)00235-9. No abstract available.
PubMed 14580622
Paulus W. Outlasting excitability shifts induced by direct current stimulation of the human brain. Suppl Clin Neurophysiol. 2004;57:708-14. doi: 10.1016/s1567-424x(09)70411-8.
PubMed 16106673
Polania R, Nitsche MA, Paulus W. Modulating functional connectivity patterns and topological functional organization of the human brain with transcranial direct current stimulation. Hum Brain Mapp. 2011 Aug;32(8):1236-49. doi: 10.1002/hbm.21104. Epub 2010 Jul 6.
PubMed 20607750
Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.
PubMed 17452283
Richards LG, Latham NK, Jette DU, Rosenberg L, Smout RJ, DeJong G. Characterizing occupational therapy practice in stroke rehabilitation. Arch Phys Med Rehabil. 2005 Dec;86(12 Suppl 2):S51-S60. doi: 10.1016/j.apmr.2005.08.127.
PubMed 16373140

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility Testing of tDCS and Metacognitive Strategy Training in Chronic Stroke
ClinicalTrials.gov ID: NCT04617548
Acronym / sponsor ID: 2009451
Conditions: Chronic Stroke
Keywords: Stroke, Metacognitive Strategy Training, Brain Stimulation, CO-OP, tDCS
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: University of Missouri-ColumbiaUniversity, hospital or other
Study start: 1 Jan 2020 (actual)
Primary completion: 31 Dec 2021 (actual)
Study completion: 1 Jan 2022 (actual)
First posted: 5 Nov 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
tDCS and CO-OP Group	Experimental	Combination Product: tDCS and CO-OP GroupOne-hour session three times per week for 4 weeks. Participants will receive anodal tDCS (1.5 mA) to the dorsolateral prefrontal cortex (dlPFC) for 20 minutes at the beginning of each session. Following each tDCS session, the participants will complete a sensations questionnaire.The basis for each session will be task-based practice of client-chosen goals and the use of cognitive strategies using CO-OP.

Who may qualify

Ages: 30 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

> 6 months post mild to moderate ischemic stroke
self-reported functional limitations
Age 30-80

Key exclusion criteria (11 listed)

history of other neurological diagnoses
cognitive impairment (less than or equal to 21 on the Montreal Cognitive Assessment)
severe aphasia (greater than or equal to 2 on the NIHSS language item
non-English speaking
any additional condition where the PI deems participation unsafe

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tDCS and CO-OP GroupAlso: Brain Stimulation and Metacognitive StrategyTranscranial direct current stimulation modulates the excitability of targeted brain regions, and is thought to facilitate or inhibit neuroplasticity. Participants will receive anodal tDCS (1.5 mA) to the dorsolateral prefrontal cortex (dlPFC) for 20 minutes at the beginning of each session. 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.	Combination product	tDCS and CO-OP Group

Primary outcome

Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), & Feasibility of Intervention Measure
Time frame: after study completion, an average of 5 weeks
A brief questionnaire to evaluate participant satisfaction regarding the intervention's acceptability, appropriateness, and feasibility
Semi-Structured Interview
Time frame: after study completion, an average of 5 weeks
A brief interview to gather participant perceptions of the intervention, including their perceived benefit and practicality of the intervention and suggestions for improvement for the intervention.
Client Satisfaction Questionnaire (CSQ-8)
Time frame: after study completion, an average of 5 weeks
Self-report, 8 item measures of intervention acceptability

2 secondary outcomes

Performance Quality Rating Scale (PQRS)
Time frame: Pre-intervention and post-intervention, typically an average of 5 weeks
Canadian Occupational Performance Measure (COPM)
Time frame: Pre-intervention and post-intervention, typically an average of 5 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
Background: PubMed 21440699Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015.
Background: PubMed 17453976Hartman-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.
Background: PubMed 15753425Iyer MB, Mattu U, Grafman J, Lomarev M, Sato S, Wassermann EM. Safety and cognitive effect of frontal DC brain polarization in healthy individuals. Neurology. 2005 Mar 8;64(5):872-5. doi: 10.1212/01.WNL.0000152986.07469.E9.
Background: PubMed 19403329Liebetanz D, Koch R, Mayenfels S, Konig F, Paulus W, Nitsche MA. Safety limits of cathodal transcranial direct current stimulation in rats. Clin Neurophysiol. 2009 Jun;120(6):1161-7. doi: 10.1016/j.clinph.2009.01.022. Epub 2009 Apr 28.
Background: PubMed 25416738McEwen 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.
Background: PubMed 14580622Nitsche MA, Liebetanz D, Lang N, Antal A, Tergau F, Paulus W. Safety criteria for transcranial direct current stimulation (tDCS) in humans. Clin Neurophysiol. 2003 Nov;114(11):2220-2; author reply 2222-3. doi: 10.1016/s1388-2457(03)00235-9. No abstract available.
Background: PubMed 16106673Paulus W. Outlasting excitability shifts induced by direct current stimulation of the human brain. Suppl Clin Neurophysiol. 2004;57:708-14. doi: 10.1016/s1567-424x(09)70411-8.
Background: PubMed 20607750Polania R, Nitsche MA, Paulus W. Modulating functional connectivity patterns and topological functional organization of the human brain with transcranial direct current stimulation. Hum Brain Mapp. 2011 Aug;32(8):1236-49. doi: 10.1002/hbm.21104. Epub 2010 Jul 6.
Background: PubMed 17452283Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.
Background: PubMed 16373140Richards LG, Latham NK, Jette DU, Rosenberg L, Smout RJ, DeJong G. Characterizing occupational therapy practice in stroke rehabilitation. Arch Phys Med Rehabil. 2005 Dec;86(12 Suppl 2):S51-S60. doi: 10.1016/j.apmr.2005.08.127.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing tDCS and CO-OP Group 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 11 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: finished, as of the sponsor's last update on 11 Feb 2022. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), & Feasibility of Intervention Measure (time frame: after study completion, an average of 5 weeks). The study lists 3 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 NCT04617548, which also lists 10 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 11 Feb 2022.