Brain Stimulation + Gait Training for Stroke Recovery

Overseen By Sangeetha Madhavan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Anti-spasticity, Seizure threshold

Disqualifiers: Osteoporosis, Cardiorespiratory diseases, Cognitive impairment, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 2

Duration: 8-12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve walking ability after a stroke by testing a new method that combines brain stimulation with treadmill training. Participants will receive either transcranial direct current stimulation (tDCS, a form of brain stimulation) before walking on a treadmill or a placebo version of the brain stimulation. The researchers aim to determine if this approach can enhance walking outcomes and understand its effects on the brain. This trial is suitable for individuals who had their first stroke over three months ago and still have difficulty walking but can walk for five minutes independently or with a device. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance stroke recovery methods.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on uncontrolled anti-spasticity medications or medications that could increase motor excitability and lower seizure threshold.

What prior data suggests that this brain stimulation and gait training protocol is safe for stroke recovery?

Research has shown that transcranial direct current stimulation (tDCS) is safe for stroke patients. In one study, tDCS was used in outpatient settings, and participants experienced it well with only a few minor side effects. Another study found that combining tDCS with physical training improved motor skills without significant problems.

High-intensity interval speed-based treadmill training (HIISTT) has also been shown to be safe and effective for improving walking in stroke survivors. Research indicates that participants improved their walking speed and endurance, with no major safety issues.

Overall, studies have demonstrated the safety of both tDCS and HIISTT, making them promising options for stroke recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of brain stimulation and high intensity interval speed based treadmill training (HIISTT) for stroke recovery because it introduces a novel approach to rehabilitation. Unlike traditional stroke recovery methods, which often rely on steady-paced exercises and physical therapy, this treatment uses transcranial direct current stimulation (tDCS) to prime the brain before treadmill training. This brain priming aims to enhance neuroplasticity, potentially accelerating and improving recovery outcomes. The use of tDCS before exercise might boost the brain's ability to reorganize and strengthen connections, offering a promising new pathway for stroke rehabilitation.

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

This trial will compare different approaches to enhance stroke recovery. One group of participants will receive a combination of transcranial direct current stimulation (tDCS) and ankle motor training before high-intensity interval speed-based treadmill training (HIISTT). Research has shown that combining treadmill exercises with tDCS can significantly improve walking and mobility in stroke survivors. Studies have found that this combination helps individuals walk faster and boosts brain activity related to movement. High-intensity interval training on treadmills has improved walking speed more than other treadmill methods. Preparing the brain with tDCS before exercise is emerging as a promising way to enhance the benefits of movement training. These early findings suggest that using tDCS and ankle exercises before treadmill training could lead to better walking outcomes for stroke survivors. Another group in this trial will receive sham tDCS before the treadmill training to compare the effects. ^{6 7 8 9 10}

Who Is on the Research Team?

Sangeetha Madhavan

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for adults who've had their first stroke more than 3 months ago, can walk at least 5 minutes with or without a walking aid but slower than 1.2 m/s, and have some movement in the affected leg. They shouldn't have severe muscle stiffness, major heart or lung diseases, certain mental impairments, skin conditions worsened by stimulation, metal head implants, pacemakers, recent concussions or be pregnant.

Inclusion Criteria

I am older than 18 years.

I had a stroke affecting one side of my brain over 3 months ago.

I walk slower than 1.2 meters per second.

Exclusion Criteria

You have very tight muscles in your ankles, which makes it hard to move them.

My cancer has spread to my brainstem or cerebellum.

I am not taking any uncontrolled anti-spasticity medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cortical priming using brain stimulation and high intensity interval speed based treadmill training

8-12 weeks

Weekly in-person sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ankle motor training
• High intensity interval speed based treadmill training (HIISTT)
• Transcranial direct current stimulation (tDCS)

Trial Overview The study tests if brain stimulation combined with ankle exercises and high-speed treadmill training improves walking after a stroke. It also looks into how the brain changes with this treatment. Participants will receive transcranial direct current stimulation (tDCS) alongside physical therapy interventions.

How Is the Trial Designed?

Group I: Priming+HIISTT Experimental Treatment 3 Interventions

Facilitatory transcranial direct current stimulation (tDCS) and ankle motor training before high intensity interval speed based treadmill training

Group II: Sham+HIISTT Placebo Group 1 Intervention

Sham tDCS before high intensity interval speed based treadmill training

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

University of Maryland, College Park

Collaborator

Trials

163

Recruited

46,800+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

Structured speed-dependent treadmill training (STT) significantly improved walking speed, cadence, stride length, and Functional Ambulation Category scores in 60 poststroke patients compared to limited progressive treadmill training (LTT) and conventional gait training (CGT) after 4 weeks of treatment.

The results indicate that STT is a more effective rehabilitation strategy for enhancing gait function in stroke patients, suggesting its potential as a dynamic approach to address gait dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Speed-dependent treadmill training in ambulatory hemiparetic stroke patients: a randomized controlled trial. Pohl, M., Mehrholz, J., Ritschel, C., et al.[2019]

The GAITFAST study is investigating the effectiveness of treadmill-based robot-assisted gait training (RTGT) versus therapist-assisted treadmill gait training (TTGT) in improving gait speed recovery in 120 first-ever ischemic stroke patients over a 6-month period.

This clinical trial will assess various outcomes, including gait speed and neurological impairments, to understand the mechanisms of recovery from stroke, providing valuable insights into rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of Robot-Assisted Gait Training versus Therapist-Assisted Treadmill Gait Training as Add-on Therapy in Early Subacute Stroke Patients: The GAITFAST Study Protocol. Kolářová, B., Šaňák, D., Hluštík, P., et al.[2022]

Intensive treadmill training is feasible for patients with acute ischemic stroke, with 196 out of 224 training sessions completed and only nonserious adverse events reported in 14.7% of sessions.

The training significantly increased leg activity over time, with a 133% increase in activity counts by day 5 compared to day 1, indicating that such training can greatly enhance overall physical activity in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive treadmill training in the acute phase after ischemic stroke. Strømmen, AM., Christensen, T., Jensen, K.[2018]

A study involving 180 poststroke patients found that combining functional electrical stimulation (FES) with body weight-supported treadmill training (BWSTT) significantly improved gait, balance, and lower limb function compared to BWSTT alone.

The FES plus BWSTT group showed enhanced nerve conduction and evoked potential responses, indicating a positive effect on neural recovery, with no adverse events reported during the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of functional electrical stimulation plus body weight-supported treadmill training for gait rehabilitation in patients with poststroke: a retrospective case-matched study. Bao, X., Luo, JN., Shao, YC., et al.[2020]

A 4-week high intensity speed-based treadmill training program was feasible for 16 chronic stroke survivors, with no serious adverse events reported during the training.

Participants showed significant improvements in walking speed (up to 19%) and endurance (up to 12%), and these gains were maintained for 3 months after the training, suggesting the program's effectiveness for gait training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of high intensity speed-based treadmill training on ambulatory function in people with chronic stroke: A preliminary study with long-term follow-up. Madhavan, S., Lim, H., Sivaramakrishnan, A., et al.[2020]

A randomized controlled trial with 33 chronic stroke patients showed that a 4-week treadmill training program significantly improved gait velocity and dynamic balance ability compared to traditional training, indicating its effectiveness for rehabilitation.

The study found no adverse effects from the training, suggesting that challenging treadmill speed-dependent gait and balance training is a safe and feasible option for stroke patients with low ambulation ability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of challenging treadmill speed-dependent gait and perturbation-induced balance training in chronic stroke patients with low ambulation ability: a randomized controlled trial. Hu, J., Jin, L., Wang, Y., et al.[2023]

In a study involving 19 chronic stroke patients, those who underwent treadmill walking training with rhythmic auditory stimulation (TRAS) showed significant improvements in various gait parameters compared to those who trained with over ground walking (ORAS).

The TRAS group demonstrated enhanced walking speed, step cycle, step length of the unaffected limb, and overall gait ability, suggesting that treadmill training with rhythmic auditory feedback is an effective rehabilitation method for improving gait in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between treadmill training with rhythmic auditory stimulation and ground walking with rhythmic auditory stimulation on gait ability in chronic stroke patients: A pilot study. Park, J., Park, SY., Kim, YW., et al.[2018]

A high-intensity task-oriented training program significantly improved gait speed and walking capacity in patients with subacute stroke compared to a low-intensity physiotherapy program, as shown by results from the 10-metre timed walking test and the six-minute walk test.

The study involved 44 stroke patients and demonstrated that while the high-intensity training was feasible and effective for improving gait, it did not show significant differences in balance measures, suggesting that future research should also assess physical fitness and energy expenditure during walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a high-intensity task-oriented training on gait performance early after stroke: a pilot study. Outermans, JC., van Peppen, RP., Wittink, H., et al.[2022]

A single session of high-intensity interval training (HIT) on a treadmill was found to be feasible for stroke survivors, with participants able to walk at speeds significantly faster than their usual overground walking speed, indicating potential for improved rehabilitation outcomes.

No adverse events occurred during the training, and participants reached heart rates in the vigorous exercise range, suggesting that this HIT approach is safe and could enhance cardiovascular fitness in post-stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of single session high-intensity interval training utilizing speed and active recovery to push beyond standard practice post-stroke. Aaron, SE., Gregory, CM.[2022]

Short-interval high-intensity interval training (HIIT) resulted in faster walking speeds compared to long-interval HIIT, suggesting it may be more effective for improving gait speed in stroke survivors.

Both short and long-interval HIIT sessions achieved high training intensities, but they may serve different purposes: short-interval HIIT could enhance gait speed, while long-interval HIIT may be better for improving endurance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Locomotor training intensity after stroke: Effects of interval type and mode. Boyne, P., Scholl, V., Doren, S., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11698808/

Effects of treadmill training combined with transcranial ... TT combined with active tDCS significantly improves some gait/mobility outcomes and corticomotor excitability in stroke survivors.

2. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.647338/full

Changes in Walking Speed After High-Intensity Treadmill ... In individuals with chronic stroke, HISTT leads to improvements in walking speed (15–17) that exceed progressive treadmill training with less ...

3. grantome.com grantome.com/grant/NIH/R01-HD075777-06A1

Cortical priming to optimize gait rehabilitation post stroke Cortical priming has emerged as a promising adjuvant to enhance the outcomes of motor training. Our research team has pioneered and successfully developed ...

4. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-020-00744-9

Cortical priming strategies for gait training after stroke The objective of this study was to determine if motor priming can augment the effects of HISTT on walking in chronic stroke survivors.

5. europepmc.org europepmc.org/article/med/34113308

The Effects of Transcranial Direct Current Stimulation on ... We explore the short-term effects of transcranial direct current stimulation (tDCS) on improving balance function and gait in stroke patients.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0003999321004366

Effects of High-Intensity Interval Training After Stroke (The ... HIIT combined with standard care improved walking distance, balance, and executive function immediately after the intervention compared with standard care only.

7. probiologists.com probiologists.com/article/tailoring-interval-training-in-stroke-rehabilitation-the-role-of-peak-velocity

Tailoring interval training in stroke rehabilitation In our prior studies [32,33], we demonstrated that speed-based treadmill training is not only safe but results in significant gains in walking speed and ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7429314/

Locomotor Training Intensity After Stroke: Effects of Interval ... High-intensity interval training (HIIT) is a promising strategy for improving gait and fitness after stroke, but optimal parameters remain unknown.

9. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.031532

Effect of High‐Intensity Interval Training and Moderate ... HIIT trained at the maximal tolerable treadmill speed/grade using a novel program of 2 work‐to‐recovery protocols: 30:60 and 120:180 seconds. V̇O ...

10. explorationpub.com explorationpub.com/Journals/ent/Article/1004106

The effects of high-intensity training on walking speed and ... HIT demonstrated superior outcomes in self-selected walking speed and walking endurance for individuals in the subacute phase post stroke.