Status:
RECRUITING
Effects and Mechanisms of Sensory Afferent Electrostimulation on Upper Limb Function in Patients With Hemiparesis
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
University of Bern
Conditions:
Hemiparesis
Unilateral Cerebral Palsy
Eligibility:
All Genders
6-18 years
Phase:
NA
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 underlyin...
Detailed Description
Children with hemiparesis present with sensory and motor deficits, which negatively affect quality of life and decrease participation in everyday life. To date, no treatment is yet effective to decrea...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06536634
Start Date
January 1 2025
End Date
October 1 2027
Last Update
November 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Inselspital
Bern, Switzerland, 3010