Effects and Mechanisms of Sensory Afferent Electrostimulation on Upper Limb Function in Patients … (NCT06536634) | Clinical Trial Compass
RecruitingNot Applicable
Effects and Mechanisms of Sensory Afferent Electrostimulation on Upper Limb Function in Patients With Hemiparesis
Switzerland34 participantsStarted 2025-01-01
Plain-language summary
The goal for this project is to investigate the effects of a 5-week SAES therapy in addition to conventional therapy on both behavioural (sensory and motor) and neurological measures and the underlying mechanisms of treatment response.
The goal of this project to investigate the effects of a 5-week SAES therapy in addition to conventional therapy.
The aim is to investigate whether SAES is more effective than conventional therapy alone in children with hemiparesis. The investigators will assess the efficacy of SAES using novel clinical assessment such as kinematic evaluations and modern neurophysiological measures, namely transcranial magnetic stimulation (TMS) and resting-state functional MRI (rs-fMRI).
It will be expected a benefit for children with hemiparesis after SAES training which may lead to improved bimanual and unimanual functions. Benefits have been reported in adults and in preliminary studies also in children.
Type of study: Randomised controlled clinical trial
Participants with hemiparesis will be included in the study. The study group will receive the SAES training with a glove or adhesive electrodes as a home-based training during 30 minutes per day, 5x/week, for 5 weeks, combined with conventional occupation therapy.
Researchers will compare the SAES group with a group of patients with comparable conditions who receive the prescribed conventional occupational therapy and/or physiotherapy (treatment as usual, TAU)
Who can participate
Age range
6 Years – 18 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:
* Diagnosis of unilateral cerebral palsy/hemiparesis, following unilateral brain lesion, e.g. perinatal/childhood stroke (acquired prior to the age of 16 years)
* consistent and stable limitation of hand functions
* chronic state (time since lesion \>2 years)
* aged 6-18 years
* parental informed consent if \<14 years, informed consent of the patient if \>14 years
Exclusion criteria:
* psychiatric disease that prevents the participant form informed participation and compliance in an adequate manner/setting
* Bilateral brain lesion
* Recent Botulinum toxin-injections injections (UL, \< 6 months)
* Hand surgery on paretic hand \< 2 years
* Trauma to UL in the last year
* Medical conditions that prevent training of the UL
* Participation in other afferent stimulation studies
* Electrical stimulation therapy in the last 6 months
* Intensive training of the UL (therapy more than 1x/week, \< 6 months)
If MRI and TMS is performed, additionally:
• MRI and TMS contradictions, such as
* implanted Metal devices (e.g. braces, implant)
* implanted shunt system
* in girls and women: pregnancy
* claustrophobia
* Active epilepsy
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.