tDCS + Cognitive Training for Stroke

Overseen By Anna E Boone, PhD, OTR/L

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Disqualifiers: Severe depression, Dementia, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help stroke survivors improve daily activities. It combines brain stimulation (tDCS, a gentle electrical treatment) with cognitive exercises to assess its potential to enhance recovery. Participants will join groups testing different combinations of these treatments, including CO-OP Procedures, a therapy focused on improving daily activities. The trial suits individuals over six months post-stroke, not currently in therapy, and with specific personal recovery goals. The researchers aim to refine the protocol and estimate the treatment's impact on activity performance. As an unphased trial, it provides a unique opportunity to contribute to innovative stroke recovery research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe and well-tolerated for people recovering from a stroke. In earlier studies, participants reported only mild side effects, such as tingling or itching where the device was applied. These effects were temporary and not serious.

Safety reviews for the CO-OP (Cognitive Orientation to daily Occupational Performance) procedures combined with tDCS indicate that this combination does not cause severe side effects. Most people manage any mild discomfort without problems.

Regarding computer-based cognitive training with tDCS, studies suggest it is also safe. Participants have experienced similar mild, temporary side effects, such as slight headaches or skin redness. Overall, both treatments are considered safe for use in stroke rehabilitation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of combining transcranial direct current stimulation (tDCS) with cognitive training to enhance recovery after a stroke. Unlike conventional treatments like physical therapy or medication that mainly address physical or biochemical aspects, this approach targets the brain's electrical activity to boost cognitive function. By applying anodal tDCS to the left dorsolateral prefrontal cortex, researchers aim to enhance brain plasticity and improve learning and memory in stroke patients. This could lead to more effective and faster cognitive recovery, providing a unique avenue for rehabilitation beyond current methods.

What evidence suggests that this trial's treatments could be effective for stroke?

Research shows that a gentle electrical treatment called transcranial direct current stimulation (tDCS), combined with mental exercises, can aid stroke recovery. In this trial, participants will join different groups to receive either tDCS or sham tDCS with mental exercises. Studies have found that tDCS improves language skills and thinking abilities after a stroke. Applying tDCS to the brain enhances the effectiveness of rehabilitation exercises. When paired with mental exercises, such as computer-based programs, tDCS has enhanced thinking skills and everyday abilities. These findings suggest that tDCS with mental exercises could provide additional benefits for stroke recovery. ^{5 6 7 8 9}

Who Is on the Research Team?

Anna E Boone, PhD, OTR/L

Principal Investigator

University of Missouri Occupational Therapy

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You need to have at least four personal goals that you can do.

It has been at least 6 months since my stroke.

I am not currently undergoing any therapy treatments.

Exclusion Criteria

I am experiencing severe depression.

My memory or thinking skills have been officially tested and found to be impaired.

You have any other brain or nerve conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CO-OP with tDCS, computer cognitive training with tDCS, CO-OP with sham tDCS, or computer cognitive training with sham tDCS. Each session includes 20 minutes of tDCS or sham followed by 45 minutes of the assigned intervention.

5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1-month post-intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Computer Cognitive Training Procedures
• CO-OP Procedures
• sham tDCS group
• tDCS

Trial Overview

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.

How Is the Trial Designed?

Group I: CO-OP and tDCS group Experimental Treatment 2 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 group Active Control 2 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 group Active Control 2 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 group Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Published Research Related to This Trial

In a pilot study involving 23 stroke survivors, both groups receiving robot-assisted therapy (RAT) showed significant improvements in upper extremity function, as measured by the Fugl-Meyer Assessment, after 10 treatment sessions.

The combination of bilateral tDCS with RAT appeared to be more beneficial for patients with chronic and subcortical strokes, suggesting that the effectiveness of this treatment may vary based on the type and duration of the stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

tDCS and Robotics on Upper Limb Stroke Rehabilitation: Effect Modification by Stroke Duration and Type of Stroke. Straudi, S., Fregni, F., Martinuzzi, C., et al.[2018]

The combination of metacognitive strategy training (MCST) and transcranial direct current stimulation (tDCS) was found to be feasible and well-accepted by chronic stroke participants, with 12 sessions conducted over 4 weeks.

Participants showed significant improvements in both performance and satisfaction regarding their occupational goals, indicating that this intervention could effectively enhance daily life tasks post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Augmenting Cognitive Strategy Training With Non-Invasive Brain Stimulation. Boone, AE., Noe, J., Wolf, TJ.[2023]

In a study involving 56 chronic stroke patients, transcranial direct current stimulation (tDCS) combined with motor training significantly enhanced the learning of a new fine motor skill compared to training alone, particularly during the online learning phase.

While tDCS improved the acquisition of the trained skill, it did not affect long-term retention or the generalization of performance gains to untrained tasks, indicating its benefits are specific to the skill being practiced.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation Enhances Motor Skill Learning but Not Generalization in Chronic Stroke. Hamoudi, M., Schambra, HM., Fritsch, B., et al.[2020]

This study aims to evaluate the safety and effectiveness of personalized transcranial direct current stimulation (P-tDCS) in promoting awakening in 24 patients with disorders of consciousness (DOC) after acquired brain injury, using a tailored approach based on individual brain lesions.

The trial will compare the effects of P-tDCS combined with typical rehabilitation against sham tDCS over a 2-week period, assessing outcomes using the Korean version of the Coma Recovery Scale-Revised (K-CRS-R) to measure improvements in consciousness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and therapeutic effects of personalized transcranial direct current stimulation based on electrical field simulation for prolonged disorders of consciousness: study protocol for a multi-center, double-blind, randomized controlled trial. Yoon, MJ., Oh, HM., Kim, T., et al.[2023]

Transcranial direct current stimulation (tDCS) combined with cognitive training significantly improved executive function and performance in daily activities among 50 stroke patients, as measured by various cognitive tests.

While most cognitive assessments showed significant improvements in the tDCS group compared to the sham group, some specific tasks related to daily living did not show notable differences, indicating that tDCS may be more effective for certain cognitive functions than others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Explore combined use of transcranial direct current stimulation and cognitive training on executive function after stroke. Liu, YW., Chen, ZH., Luo, J., et al.[2022]

In a study involving 21 chronic hemiparetic stroke patients, bimanual motor skill learning and retention were successfully achieved through training on a cooperative task, indicating the potential of this approach for neurorehabilitation.

However, the application of dual-tDCS did not significantly enhance the learning or retention of these motor skills compared to a sham treatment, suggesting that while tDCS may not improve outcomes, the training itself is beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning a Bimanual Cooperative Skill in Chronic Stroke Under Noninvasive Brain Stimulation: A Randomized Controlled Trial. Doost, MY., Orban de Xivry, JJ., Herman, B., et al.[2020]

In a study of 26 chronic stroke patients with cognitive impairment, remotely supervised transcranial direct current stimulation (RS-tDCS) significantly improved cognitive function, particularly in those with moderate cognitive decline and lower baseline scores.

RS-tDCS was found to be safe and feasible for home-based rehabilitation, with a high adherence rate of 98.4% and no serious adverse effects reported, suggesting it could be a valuable tool for enhancing cognitive training after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Transcranial Direct Current Stimulation to Enhance Cognition in Stroke: Randomized Controlled Trial. Ko, MH., Yoon, JY., Jo, YJ., et al.[2022]

Transcranial direct current stimulation (TDCS) applied to the affected hemisphere in 50 acute stroke patients was found to be safe, with no side effects reported during the treatment.

Despite being safe, the five daily sessions of anodal TDCS did not lead to significant improvements in motor deficits compared to sham treatment, indicating that TDCS may not enhance clinical outcomes in acute stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation of the affected hemisphere does not accelerate recovery of acute stroke patients. Rossi, C., Sallustio, F., Di Legge, S., et al.[2015]

Transcranial direct current stimulation (tDCS) was safely integrated into a physiotherapy program for an adolescent with severe traumatic brain injury, with the only notable side effect being mild itchiness under the electrodes.

The combination of tDCS and physiotherapy led to significant improvements in gross motor function, with the participant progressing from using a wheelchair to walking with a walker and achieving a 33.1% increase in their Gross Motor Function Measure score.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Transcranial Direct Current Stimulation into an Existing Inpatient Physiotherapy Program to Enhance Motor Learning in an Adolescent with Traumatic Brain Injury: A Case Report. Ryan, JL., Beal, DS., Levac, DE., et al.[2023]

A systematic review of 64 studies involving 2262 participants found that transcranial direct current stimulation (tDCS) has a low dropout rate (6% for active and 7.2% for sham), indicating good acceptability among participants.

Despite the low dropout rates, many studies inadequately reported adverse events (AEs), highlighting a need for improved guidelines to standardize AE reporting in tDCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. Aparício, LVM., Guarienti, F., Razza, LB., et al.[2018]

In a study involving 64 patients with chronic stroke, combining real transcranial direct current stimulation (tDCS) with motor imagery and upper-limb functional training significantly improved upper-limb function, as measured by the Fugl-Meyer scale and Action Research Arm Test.

The experimental group receiving real tDCS showed substantial reductions in impairment and disability compared to the control group, indicating that this combined approach may enhance rehabilitation outcomes for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Transcranial Direct Current Stimulation Augmented with Motor Imagery and Upper-Limb Functional Training for Upper-Limb Stroke Rehabilitation: A Prospective Randomized Controlled Trial. Kashoo, FZ., Al-Baradie, RS., Alzahrani, M., et al.[2023]

A new initiative called CO-OP KT aims to improve access to rehabilitation for stroke patients with cognitive impairments by training healthcare professionals in a function-based approach, potentially leading to better patient outcomes.

The study will evaluate the effectiveness of CO-OP KT in changing clinician practices and improving patient activity and self-efficacy over time, using a combination of quasi-experimental designs and assessments at multiple follow-up points.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-faceted knowledge translation approach to support persons with stroke and cognitive impairment: evaluation protocol. McEwen, SE., Donald, M., Dawson, D., et al.[2023]

In a study of 57 chronic post-stroke patients, five sessions of transcranial direct current stimulation (tDCS) combined with physiotherapy significantly improved upper limb function compared to a sham treatment, indicating its efficacy in rehabilitation.

After ten sessions, the improvements in upper limb function were even greater, suggesting that more tDCS sessions can lead to enhanced recovery outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do Higher Transcranial Direct Current Stimulation Doses Lead to Greater Gains in Upper Limb Motor Function in Post-Stroke Patients? Pires, R., Baltar, A., Sanchez, MP., et al.[2023]

Transcranial direct current stimulation (tDCS) was found to be feasible and safe for use in outpatient therapy for stroke patients, with 100% adherence among the 7 participants who completed the study over 5-6 weeks.

Most participants (71%) reported positive impressions of tDCS, experiencing acute improvements in function and energy, with only one adverse event unrelated to the treatment and mild side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Transcranial Direct Current Stimulation in an Outpatient Rehabilitation Setting After Stroke. Cleland, BT., Galick, M., Huckstep, A., et al.[2020]

Transcranial direct current stimulation (tDCS) shows very low to moderate evidence of effectiveness in improving activities of daily living (ADL) after stroke, but results may not be reliable due to issues with trial design, particularly allocation concealment.

There is no strong evidence that tDCS improves arm and leg function, muscle strength, or cognitive abilities in stroke patients, although it may have a very low quality effect on hemispatial neglect, and it does not increase the risk of adverse events or dropouts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Elsner, B., Kugler, J., Pohl, M., et al.[2022]

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Transcranial Direct Current Stimulation in Stroke Rehabilitation

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In this review, we will systematically examine and discuss the hurdles and challenges in using tDCS as a brain modulation tool to enhance and facilitate ...

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Patient-tailored transcranial direct current stimulation to ...

The study will show the feasibility and test the efficacy of personalized, multi-electrode anodal TDCS of M1-HAND in patients with subacute stroke patients.

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NCT04617548 | tDCS and CO-OP in Chronic Stroke

Transcranial direct current stimulation modulates the excitability of targeted brain regions, and is thought to facilitate or inhibit neuroplasticity.

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This review analyzes the reported adverse effects in stroke, looking for factors that may induce side-effects.

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This study aims to determine the feasibility and safety of applying tDCS treatment using optimized and personalized tDCS electrode positions in patients with ...

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tDCS + Cognitive Training for Stroke · Info for Participants

This N/A medical study run by University of Missouri-Columbia needs participants to evaluate whether CO-OP Procedures will have tolerable side effects ...