Effects and Mechanisms of Sensory Afferent Electrostimulation on Upper Limb Function in Patients With Hemiparesis
Insel Gruppe AG, University Hospital Bern
34 participants
Jan 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria16
- 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
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Interventions
The experimental intervention consists of SAES with a glove or adhesive electrodes at 20Hz, 300µs, intensity between 2-10mA, during 30 minutes per day, 5x/week, for 5 weeks, combined with conventional occupation therapy. The subsequent therapy sessions will take place at home, with in-between telephone checks.
Treatment as usual
Locations(1)
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NCT06536634