Actively Recruiting
Effects and Mechanisms of Sensory Afferent Electrostimulation on Upper Limb Function in Patients With Hemiparesis
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-11-20
34
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
Sponsors
I
Insel Gruppe AG, University Hospital Bern
Lead Sponsor
U
University of Bern
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Effects and Mechanisms of Sensory Afferent Electrostimulation on Upper Limb Function in Patients With Hemiparesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of unilateral cerebral palsy or hemiparesis from a brain lesion occurring before age 16
- Stable and consistent limitation of hand functions
- Chronic condition with brain lesion older than 2 years
- Age between 6 and 18 years
- Parental consent if under 14 years; patient consent if 14 years or older
You will not qualify if you...
- Psychiatric disease preventing informed participation and compliance
- Bilateral brain lesion
- Botulinum toxin injections in the upper limb within the last 6 months
- Hand surgery on the affected hand within the last 2 years
- Upper limb trauma in the past year
- Medical conditions preventing upper limb training
- Participation in other afferent stimulation studies
- Electrical stimulation therapy in the last 6 months
- Intensive upper limb training (more than once a week) in the last 6 months
- MRI or TMS contraindications such as implanted metal devices or shunt systems
- Pregnancy in girls or women
- Claustrophobia
- Active epilepsy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Inselspital
Bern, Switzerland, 3010
Actively Recruiting
Research Team
A
Alisa Gschaidmeier, Dr. med.
CONTACT
S
Sebastian Grunt, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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