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

NCT06536634 | Recruiting DMC

• 1 other identifier: 2024-00982
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Hemiparesis; Unilateral Cerebral Palsy

Keywords

Sensory afferent electrostimulation; MRI; TMS; Motor function; Sensory function; Sensor

Outcome Measures

Primary Outcomes (1)

• Bimanual hand function

  Will be measured with the Assisting Hand Assessment (AHA)

  5 weeks (After the treatment)

Secondary Outcomes (17)

• Bimanual hand function

  2 assessments: baseline, follow up (12 weeks)

• Bimanual hand function in everyday life activities

  2 assessments: baseline, follow up (12 weeks)

• Spasticity

  3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)

• Strength

  3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)

• Sensitivity

  3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)

Study Arms (2)

SAES

EXPERIMENTAL

Treatment group (SAES) Interventions: Sensory afferent electrical stimulation (SAES)

Other: SAES

Control group

OTHER

The control intervention (treatment as usual, TAU) consists of the prescribed conventional occupational therapy and/or physiotherapy.

Other: TAU

Interventions

SAES OTHER

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.

SAES

TAU OTHER

Treatment as usual

Control group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (1)

Inselspital

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Paresis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Regula Everts, Prof. Dr.

  Insel Gruppe AG, University Hospital Bern

  STUDY CHAIR

• Grunt Sebastian, Prof. Dr.

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

• Nef Tobias, Prof. Dr.

  ARTORG

  STUDY CHAIR

• Wiest Roland, Prof. Dr.

  Insel Gruppe AG, University Hospital Bern

  STUDY CHAIR

• Seidel Kathleen, Prof. Dr.

  Insel Gruppe AG, University Hospital Bern

  STUDY CHAIR

Central Study Contacts

Alisa Gschaidmeier, Dr. med.

CONTACT

031 632 94 24; alisa.gschaidmeier@insel.ch

Sebastian Grunt, Prof. Dr.

CONTACT

031 632 94 24

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized controlled Bayesian phase II trial with a follow-up examination after 12 weeks mwas designed. The study participants will be recruited via the University Children's Hospital Bern and the Swiss Cerebral Palsy Registry.

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: August 5, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)