Sensory nerve stimulation to improve hand and arm function in children with hemiparesis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized controlled trial comparing 5 weeks of Sensory Afferent Electrostimulation (SAES) plus conventional therapy versus conventional therapy alone in children with unilateral cerebral palsy/hemiparesis. Outcomes include clinical sensory and motor measures, detailed kinematic assessments, and neurophysiological and imaging biomarkers using transcranial magnetic stimulation (TMS) and resting-state functional MRI (rs-fMRI). The study aims to measure both functional gains in unimanual and bimanual tasks and underlying changes in corticospinal excitability and brain network connectivity. Participants attend in-person treatment and assessment sessions at the study center over the intervention period.

Why it matters

Who can join: the full rules

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

Where it's running

• Inselspital
  Bern, Switzerland Recruiting

Study contacts

• Principal investigator: Grunt Sebastian, Prof. Dr. — Insel Gruppe AG, University Hospital Bern
• Study coordinator: Alisa Gschaidmeier, Dr. med.
• Email: alisa.gschaidmeier@insel.ch
• Phone: 031 632 94 24

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.