Sensory nerve stimulation to improve hand and arm function in children with hemiparesis
Effects and Mechanisms of Sensory Afferent Electrostimulation on Upper Limb Function in Patients With Hemiparesis
This trial will try adding 5 weeks of sensory afferent electrostimulation (SAES) to usual therapy to see if it helps children aged 6–18 with hemiparesis improve sensation and movement in the affected upper limb.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT06536634 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial comparing 5 weeks of Sensory Afferent Electrostimulation (SAES) plus conventional therapy versus conventional therapy alone in children with unilateral cerebral palsy/hemiparesis. Outcomes include clinical sensory and motor measures, detailed kinematic assessments, and neurophysiological and imaging biomarkers using transcranial magnetic stimulation (TMS) and resting-state functional MRI (rs-fMRI). The study aims to measure both functional gains in unimanual and bimanual tasks and underlying changes in corticospinal excitability and brain network connectivity. Participants attend in-person treatment and assessment sessions at the study center over the intervention period.
Who should consider this trial
Good fit: Children aged 6–18 years with chronic unilateral cerebral palsy/hemiparesis from a unilateral brain lesion (lesion >2 years prior) and stable limitations of hand function are ideal candidates, provided they meet safety and participation criteria.
Not a fit: Children with bilateral brain lesions, recent upper-limb surgery or botulinum-toxin injections, recent intensive upper-limb training, major medical or psychiatric contraindications, or inability to undergo MRI/TMS are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding SAES could improve hand and arm sensation and function in children with hemiparesis and support longer-term gains in unimanual and bimanual abilities.
How similar studies have performed: SAES has shown positive effects in adults after stroke and in small preliminary pediatric reports, but larger randomized trials in children with mechanistic TMS and rs-fMRI measures are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bern
- Inselspital — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Grunt Sebastian, Prof. Dr. — Insel Gruppe AG, University Hospital Bern
- Study coordinator: Alisa Gschaidmeier, Dr. med.
- Email: alisa.gschaidmeier@insel.ch
- Phone: 031 632 94 24
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.