NCT06536634 Effects and Mechanisms of Sensory Afferent Electrostimulation on Upper Limb Function in Patients With Hemiparesis
| NCT ID | NCT06536634 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Hemiparesis |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 34 participants in total. It began in 2025-01-01 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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)
Eligibility 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
Contact & Investigator
Regula Everts, Prof. Dr.
STUDY CHAIR
Insel Gruppe AG, University Hospital Bern
Frequently Asked Questions
Who can join the NCT06536634 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying Hemiparesis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06536634 currently recruiting?
Yes, NCT06536634 is actively recruiting participants. Contact the research team at alisa.gschaidmeier@insel.ch for enrollment information.
Where is the NCT06536634 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT06536634 clinical trial?
NCT06536634 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Regula Everts, Prof. Dr. at Insel Gruppe AG, University Hospital Bern. The trial plans to enroll 34 participants.