t-RNS After Hand Recovery in Chronic Stroke (NCT05489146) | Clinical Trial Compass
CompletedNot Applicable
t-RNS After Hand Recovery in Chronic Stroke
United States14 participantsStarted 2015-01-15
Plain-language summary
Upper extremity (UE) paresis or weakness is one of the most frequent impairments after stroke. Despite intense rehabilitation, motor and functional recovery of patients with severe hand impairments is poor. Hence, there is a need for more effective treatments to enhance motor function in patients with severe hand impairments after stroke. Adaptive functional electrical stimulation (FES) appears to be a promising treatment and has the potential to facilitate active movement in individuals with severe impairments post-stroke. In addition, transcranial random noise stimulation (trns) is a widely studied, non-invasive and safe method to enhance the corticomotor excitability in individuals with chronic stroke. However, the effect of combining trns and adaptive FES in patients with severe hand impairments has not been investigated. Therefore, the purpose of this study is to investigate whether combining trns with FES will enhance hand function in individuals with chronic stroke than FES alone. The investigators predict that combining trns with FES will significantly enhance hand function than FES alone.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 or older
* Episode (1 or more than one) of stroke at least 6 months prior
* Able to follow 3-step commands to rule out severe aphasia
* Unilateral hemiparesis
* Able to speak english
* No active drug or alcohol abuse, schizophrenia, other neurological or medical conditions that would confound results, or refractory depression
* Able to actively flex and extend the more-affected shoulder and elbow at least 30°.
* Able to elicit motor evoked potential in the flexor carpii radialis and extensor carpii radialis muscles of the affected hand.
Exclusion Criteria:
* Spasticity greater than equal to 2 on the Modified Ashworth Scale in shoulder, elbow, wrist and finger joints of the more-affected upper extremity
* Scores \> 3 on the Amount scale of Motor Activity Log indicating good use of the more-affected hand
* Has ataxia determined via finger-to-nose testing section of the Fugl Meyer Upper Extremity assessment
* Has proprioceptive sensory deficits determined via a score of 2 on the position sense section (section H) of the Fugl Meyer Upper Extremity assessment proprioception
* Excessive pain \> equal to 4 on Visual Analog Scale in the more-affected upper extremity
* Skin lesions on the more-affected upper extremity and scalp
* Individuals with implanted devices that may be affected by electrical stimulation
* Participating in concurrent therapy
* Individuals with seizures
* History of seizures, schizophrenia, Bipolar disorder (type I or II) \[Answer …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Fugl Meyer Upper Extremity Scale at Post Treatment
Timeframe: Baseline, 6 weeks.
2
Change From Baseline in Fugl Meyer Upper Extremity Scale at 3 Months Post Treatment