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

28 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment tDCS + Cognitive Training for Stroke?

Research shows that combining transcranial direct current stimulation (tDCS) with other therapies, like motor imagery and functional training, can improve upper limb function in stroke patients. Additionally, tDCS has been found to enhance the effects of standard physiotherapy and improve activities of daily living and cognitive functioning in stroke survivors. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for humans?

Research shows that tDCS is generally safe for humans, with mild to moderate side effects like tingling, itching, pinching, and fatigue. Most adverse events reported are unrelated to tDCS, and the side effects are usually temporary. ^{6 7 8 9 10}

How does the tDCS + Cognitive Training treatment for stroke differ from other treatments?

The tDCS + Cognitive Training treatment is unique because it combines non-invasive brain stimulation (tDCS) with cognitive strategy training to improve daily life task performance in stroke patients. This approach is novel as it targets both brain activity and cognitive skills, which is different from traditional physical rehabilitation methods. ^{11 12 13 14 15}

Research Team

Anna E Boone, PhD, OTR/L

Principal Investigator

University of Missouri Occupational Therapy

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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) 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]

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) 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]

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]

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]

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]

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 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 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]

References

1. Switzerland 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

tDCS and Robotics on Upper Limb Stroke Rehabilitation: Effect Modification by Stroke Duration and Type of Stroke. [2018]

3. England pubmed.ncbi.nlm.nih.gov

A multi-faceted knowledge translation approach to support persons with stroke and cognitive impairment: evaluation protocol. [2023]

4. Switzerland 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? [2023]

5. England 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. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Transcranial Direct Current Stimulation in an Outpatient Rehabilitation Setting After Stroke. [2020]

7. England 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Home-Based Transcranial Direct Current Stimulation to Enhance Cognition in Stroke: Randomized Controlled Trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation of the affected hemisphere does not accelerate recovery of acute stroke patients. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Augmenting Cognitive Strategy Training With Non-Invasive Brain Stimulation. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Learning a Bimanual Cooperative Skill in Chronic Stroke Under Noninvasive Brain Stimulation: A Randomized Controlled Trial. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation Enhances Motor Skill Learning but Not Generalization in Chronic Stroke. [2020]

14. Switzerland 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. [2023]

15. Sweden pubmed.ncbi.nlm.nih.gov

Explore combined use of transcranial direct current stimulation and cognitive training on executive function after stroke. [2022]