Effects and Mechanisms of Sensory Afferent Electrostimulation on Upper Limb Function in Patients With Hemiparesis
Key facts
- Who runs it
- Insel Gruppe AG, University Hospital Bern
- Where
- Switzerland1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 34 people, planned
- Started
- 1 Jan 2025
- Expected to end
- 1 Oct 2027
- Type of study
- Interventional, 2 groups
- Treatments tested
- SAES
- TAU
- Record updated
- 20 November 2025
Who can take part
- Age
- 6 years to 18 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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:
- implanted Metal devices (e.g. braces, implant)
- psychiatric disease that prevents the participant form informed participation and compliance in an adequate manner/setting
- Medical conditions that prevent training of the UL
- Active epilepsy
- Hand surgery on paretic hand < 2 years
- Bilateral brain lesion
- Recent Botulinum toxin-injections injections (UL, < 6 months)
- Trauma to UL in the last year
- Participation in other afferent stimulation studies
- MRI and TMS contradictions, such as
- implanted shunt system
- in girls and women: pregnancy
- claustrophobia
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 18 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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)
The 2 groups in the trial
- SAESTreatment being tested
Treatment group (SAES) Interventions: Sensory afferent electrical stimulation (SAES)
- Control groupOther group
The control intervention (treatment as usual, TAU) consists of the prescribed conventional occupational therapy and/or physiotherapy.
Treatment: TAU
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT06536634, who can take part
- Publications
- Record updated
- 20 November 2025