Using brain stimulation to improve walking after stroke

Cortical Priming to Optimize Gait Rehabilitation: Renewal

This study is testing if using brain stimulation along with treadmill and ankle training can help stroke survivors walk better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Illinois at Chicago (Academic / other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT04477330 on ClinicalTrials.gov

What this trial studies

This project aims to enhance gait rehabilitation for stroke survivors by employing cortical priming through transcranial direct current stimulation (tDCS) alongside traditional motor training techniques. The intervention includes high-intensity interval speed-based treadmill training and ankle motor training to improve walking outcomes. The study will also investigate the neural mechanisms that contribute to the effectiveness of this combined approach. Participants will engage in a long-term rehabilitation protocol designed to optimize their walking abilities post-stroke.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 who have experienced a first-ever monohemispheric stroke more than three months prior and have residual gait deficits.

Not a fit: Patients with severe osteoporosis, significant contractures, or uncontrolled medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve walking abilities and overall mobility for stroke survivors.

How similar studies have performed: Other studies utilizing brain stimulation techniques have shown promise in enhancing rehabilitation outcomes, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Age greater than 18 years
* First ever monohemispheric stroke \> 3 months since onset
* Residual hemiparetic gait deficits (e.g. abnormal gait pattern)
* Able to walk for 5 minutes at self-paced speed. Handheld assistive device is acceptable.
* Walking speed lesser than 1.2 m/s
* Lower limb Fugl-Meyer Motor score between 15-30
* At least 5 deg of ankle dorsiflexion necessary to perform the ankle-tracking task

Exclusion Criteria:

* General exclusion criteria

  * Severe osteoporosis
  * Contracture-limiting range of motion of lower limb
  * Score of more than 2 on the Modified Ashworth Scale (indicating increased muscle tone through ankle range of motion)
  * Uncontrolled anti-spasticity medications during the study period
  * Score less than 6 on the Fugl-Meyer Sensory Assessment Scale for the Lower Limb
  * Cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema)
  * Unhealed decubiti, persistent infection
  * Significant cognitive or communication impairment (Mini-Mental State Examination (MMSE)\<21), which could impede the understanding of the purpose of procedures of the study or prevent the patient from performing the ankle-tracking task.
  * Lesions involving the brainstem and cerebellum
  * Failure to pass the graded exercise stress test

TMS exclusion criteria

* Implanted cardiac pacemaker
* Metal implants in the head or face
* Unexplained, recurring headaches
* History of seizures or epilepsy
* Currently under medication that could increase motor excitability and lower seizure threshold
* Skull abnormalities or fractures
* Concussion within the last 6 months
* Currently pregnant

tDCS exclusion criteria

* Skin hypersensitivity
* History of contact dermatitits
* History of allodynia and/or hyperalgesia
* Any other skin or scalp condition that could be aggravated by tDCS

Where this trial is running

Chicago, Illinois

• Physical Therapy — Chicago, Illinois, United States (Recruiting)

Study contacts

• Principal investigator: Sangeetha Madhavan — University of Illinois at Chicago
• Study coordinator: Sangeetha Madhavan

Conditions Stroke; tDCS; Walking