Tele-Cross Education for severe stroke

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

The trial compares two home-based programs delivered with remote supervision: Tele-Cross Education, which uses unilateral training of the unaffected leg, and Tele-control, which includes cognitive tasks and unilateral movements. Each participant undergoes both conditions with pre- and post-intervention assessments of brain activity, spinal measures, and motor function. The study aims to determine feasibility, participant acceptance, and potential neuroplastic and functional benefits in chronic, monohemispheric, severe stroke. Recruitment is limited to adults with chronic, severe unilateral stroke and adequate cognitive capacity, and it excludes individuals with confounding neurological conditions, significant language barriers, or certain medical or anatomical contraindications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Single, monohemispheric stroke
* Chronic stroke (\> 6 months prior)
* Severe stroke (Fugl-Meyer Lower Extremity motor scale score \< 21 or 6 Minute Walk Test distance \< 300m)

Exclusion Criteria:

* Use of anti-spasticity medications
* Existence of other neurological disorders
* Have brainstem or cerebellar lesions.
* Mini-Mental State Examiniation score of \<21, to ensure participants have the cognitive capacity to consent and can understand instructions both in-person and during remote supervision.
* Non-English-speaking individuals
* Bone, joint or soft tissue injury
* Uncontrolled medical conditions (such as uncontrolled hypertension, untreated cardiac disease, or untreated pulmonary disease)
* Unable to see the tablet and zoom screen
* Unable to move non-paretic ankle (\< 5 degrees of ankle ROM)
* Fugl-Meyer Lower Extremity sensory scale score \< 6

TMS exclusion criteria

* Previous adverse reaction to TMS
* Skull abnormalities or fractures
* Concussion within the prior 6 months
* Unexplained, recurring headaches
* Implanted cardiac pacemaker
* Metal implants in the head or face
* History of seizures or epilepsy
* Use of medications that could alter cortical excitability or increase risk of seizure (e.g., antidepressants, antipsychotics, anxiolytics, anticonvulsants)
* Current pregnancy

PNS exclusion criteria

* Skin hypersensitivity at any sites of stimulation, including the scalp, thoracolumbar spine, and peripheral limbs
* History of contact dermatitis at any of the sites of stimulation
* History of allodynia and/or hyperalgesia
* Active skin infection
* Skin lesions
* Deep vein thrombosis
* Any other skin or scalp condition that could be aggravated by stimulation
* Implanted electronic, metallic, or highly conductive devices near site of stimulation that cannot be removed without permission from a health professional

Where it's running

• Brain Plasticity Lab
  Chicago, Illinois, United States Recruiting

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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.