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Effects and Mechanisms of Sensory Afferent Electrostimulation on Upper Limb Function in Patients With Hemiparesis

RecruitingNAAges 6 Years - 18 YearsAllInsel Gruppe AG, University Hospital Bern
NCT06536634 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 i

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📋 Eligibility rules (as published)
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
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What it tests

  • SAES
  • TAU
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Where

1 site
Inselspital
Bern, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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