tDCS and CO-OP in Chronic Stroke

NCT04617548 | Completed Phase 1 FDA Device

• 1 other identifier: 2009451
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Stroke

Keywords

Stroke; Metacognitive Strategy Training; Brain Stimulation; CO-OP; tDCS

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  after study completion, an average of 5 weeks

• Client Satisfaction Questionnaire (CSQ-8)

  Self-report, 8 item measures of intervention acceptability

  after study completion, an average of 5 weeks

Secondary Outcomes (2)

• Performance Quality Rating Scale (PQRS)

  Pre-intervention and post-intervention, typically an average of 5 weeks

• Canadian Occupational Performance Measure (COPM)

  Pre-intervention and post-intervention, typically an average of 5 weeks

Study Arms (1)

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.

Combination Product: tDCS and CO-OP Group

Interventions

tDCS and CO-OP Group COMBINATION_PRODUCT

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.

Also known as: Brain Stimulation and Metacognitive Strategy

tDCS and CO-OP Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 652122, United States

Location

Related Publications (10)

• 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.

  PMID: 21440699 BACKGROUND

• 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.

  PMID: 17453976 BACKGROUND

• 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.

  PMID: 15753425 BACKGROUND

• 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.

  PMID: 19403329 BACKGROUND

• 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.

  PMID: 25416738 BACKGROUND

• 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.

  PMID: 14580622 BACKGROUND

• 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.

  PMID: 16106673 BACKGROUND

• 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.

  PMID: 20607750 BACKGROUND

• 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.

  PMID: 17452283 BACKGROUND

• 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.

  PMID: 16373140 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anna E. Boone, MSOT, PhD, OTR/L

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: November 5, 2020
• Study Start: January 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: January 1, 2022
• Last Updated: February 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)