Improving movement after stroke using electrical spinal cord stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of non-invasive transcutaneous spinal cord stimulation combined with gait training for individuals with hemiplegia resulting from stroke. It includes a cross-over design and a randomized control trial to assess both short-term and long-term effects on gait symmetry, performance, and corticospinal circuitry. The study aims to identify optimal stimulation parameters and distinguish between responders and non-responders to the treatment. Participants will undergo tailored interventions to enhance their mobility and balance.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Age 18 years or older
* Able and willing to give written consent and comply with study procedures
* At least 6 months' post-stroke
* Hemiplegia secondary to a single stroke
* Functional Ambulation Category of 2 or greater - i.e., subject needs continuous or intermittent support of one person to help with balance and coordination.
* Not currently receiving regular physical therapy services
* Physician approval to participate

Exclusion Criteria

* Ataxia
* Multiple stroke history
* Botox injection in lower extremity within the last 4 months
* Modified Ashworth score of 3 or greater in lower extremity
* Pregnant or nursing
* Using a powered, implanted cardiac device for monitoring or support of heart function (i.e. pacemaker, defibrillator, or LVAD) or anti-spasticity implantable pumps
* Active pressure sores
* Unhealed bone fractures
* Peripheral neuropathies
* Painful musculoskeletal dysfunction due to active injuries or infections
* Severe contractures in the lower extremities
* Medical illness limiting the ability to walk
* Active urinary tract infection
* Clinically significant depression, psychiatric disorders, or ongoing drug abuse
* Active cancer or cancer in remission less than 5 years
* Orthopedic dysfunction, injury, or surgery that would impact an individual's ability to use the lower extremity.
* Traumatic brain injury or other neurological conditions that would impact the study.

TMS-Specific Exclusion Criteria: TMS will be utilized for both Aims. The sub-set of participants who meet these criteria will participate in this component of the studies.

* Medicated with agents known to increase (e.g., amphetamines) or decrease motor system excitability (e.g., lorazepam)
* Implanted cardiac pacemaker
* Metal implants in the head or face
* Suffers unexplained, recurring headaches
* Had a seizure in the past unrelated to the stroke event, or has epilepsy
* Skull abnormalities or fractures
* A concussion within the last 6 months
* Unstable cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension, uncontrolled diabetes, or chronic emphysema)

Where it's running

• Shirley Ryan AbilityLab
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Arun Jayaraman, PT, PhD — Shirley Ryan AbilityLab
• Study coordinator: Kelly McKenzie, DPT
• Email: kmckenzie@sralab.org
• Phone: 312-238-7111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

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• Web-based therapy using action observation and mirror therapy for arm weakness after stroke

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• Remote Ischaemic Conditioning for Fatigue After Stroke 2

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• Dual-task balance training plus computer-based cognitive training after stroke

  In adults who recently had a stroke, the study tests whether adding computerized cognitive exercises to balance training improves balance and other recovery outcomes.

  Recruiting Matia Foundation · San Sebastián, GUIPUZCOA · NCT07913620

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.