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

November 17, 2025 updated by: Insel Gruppe AG, University Hospital Bern

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Children with hemiparesis present with sensory and motor deficits, which negatively affect quality of life and decrease participation in everyday life. To date, no treatment is yet effective to decrease these impairments. A recent systematic review confirms that unimanual and bimanual trainings effectively improve upper limb function in children with hemiparesis. However, it is still challenging to find the best individual training method for children with hemiparesis, as there is much variability in treatment response.

In the present study, the effects and mechanisms of non-invasive electrostimulation of the hand, called Sensory Afferent Electrostimulation (SAES) will be investigated. SAES triggers action potentials in afferent nerve fibres leading to increased sensory afferent input in the sensorimotor regions of the brain. Through this, SAES can enhance excitability of the motor cortex and of upper limb performance. While proven effective in adults after stroke, SAES is safe with promising positive results in a very small study in children with hemiparesis. However, the investigation of efficacy of SAES on sensory and motor functions was so far neglected. Modern stimulation and imaging methods revealed that, whole-hand SAES induced increased strength of corticospinal projections and intracortical change (measured with transcranial magnetic stimulation), which may indicate long-term potentiation mechanisms. Furthermore, in a functional MRI study, SAES induced increased motor cortex activity. Hence, resting state fMRI will allow to understand the efficacy of SAES on the topographically connectivity of the motor and sensorimotor network at rest.

The experimental intervention consists of SAES with a glove or adhesive electrodes (e.g. Cefar Reha X2) 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.

The control intervention (treatment as usual, TAU) consists of the prescribed conventional occupational therapy and/or physiotherapy. The evaluation of the UL sensory and motor function will be conducted at the University Children's Hospital in Bern by blind assessors, expert in the clinical measures, and will take place before and after each intervention period and at 12-weeks follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Sebastian Grunt, Prof. Dr.
  • Phone Number: 031 632 94 24

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Inselspital
        • Contact:
          • Sebastian Grunt, Prof. Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SAES

Treatment group (SAES)

Interventions: Sensory afferent electrical stimulation (SAES)
Other: SAES
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.
Other: Control group
The control intervention (treatment as usual, TAU) consists of the prescribed conventional occupational therapy and/or physiotherapy.
Other: TAU
Treatment as usual

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bimanual hand function
Time Frame: 5 weeks (After the treatment)
Will be measured with the Assisting Hand Assessment (AHA)
5 weeks (After the treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bimanual hand function
Time Frame: 2 assessments: baseline, follow up (12 weeks)
Will be measured with the Assisting Hand Assessment (AHA)
2 assessments: baseline, follow up (12 weeks)
Bimanual hand function in everyday life activities
Time Frame: 2 assessments: baseline, follow up (12 weeks)
Will be measured with the Chedoke Arm and Hand Activity Inventory (CAHAI)
2 assessments: baseline, follow up (12 weeks)
Sensitivity
Time Frame: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Will be assessed via clinical assessments (Semmes-Weinstein monofilaments)
3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Unimanual hand function
Time Frame: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Will be assessed via clinical assessments (Jebson-Taylor Hand function test)
3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Hand function during daily activities
Time Frame: 2 assessments: baseline, after the treatment (5 weeks)
Will be assessed via questionnaires (CHEQ)
2 assessments: baseline, after the treatment (5 weeks)
Mirror movements
Time Frame: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Will be assessed via clinical assessments (Woods and Teuber Scale)
3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Upper limb kinematic activity
Time Frame: 2 assessments: baseline, after the treatment (5 weeks)
Will be assessed with novel sensory measures in an instrumented apartment using DeepLabCut software
2 assessments: baseline, after the treatment (5 weeks)
TMS - Neurophysiological outcomes
Time Frame: 2 assessments: baseline, after the treatment (5 weeks)
Neuro-navigated TMS will be used at the Department for Neurosurgery at the University Hospital Bern. Neuro-navigated TMS allows a 3D brain reconstruction to topographically map the neurophysiological responses at the cortical and subcortical levels, using single-pulse (resting and active motor thresholds, motor evoked potential amplitudes and latencies and stimulus recruitment curves) and paired-pulse (intracortical interactions) protocols.
2 assessments: baseline, after the treatment (5 weeks)
Quality of life of Children with hemiparesis
Time Frame: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Will be assessed via the Kidscreen-52 questionnaire, which was designed to address generic health related quality of life.
3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Quality of life of Children with hemiparesis regarding hand function
Time Frame: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Will be assessed via the Children's Hand-use Experience Questionnaire (CHEQ). It has been developed for children and adolescents with decreased function in one hand, to evaluate the experience of children and adolescents in using the affected hand in activities where usually two hands are needed.
3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Reported Pain
Time Frame: Daily during the treatment phase (duration of treatment phase 5 weeks)
Will be assessed via a visual analogue scale regarding the experienced pain on the paretic hand before and after the electrical stimulation.
Daily during the treatment phase (duration of treatment phase 5 weeks)
Spasticity
Time Frame: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Will be assessed via clinical assessments (Modified Ashworth scale)
3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Strength
Time Frame: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Will be assessed via clinical assessments (Dynamometer)
3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Stereognosis
Time Frame: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Will be assessed via clinical assessments (Stereognosis test with Jamar toolkit)
3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Hand/wrist position
Time Frame: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
The Zancolli Wrist Classification categorizes the most commonly observed wrist and hand deformities of children with spastic CP and the relative contributions of intrinsic and extrinsic muscles to hand deformity and function.
3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Hand/Finger position
Time Frame: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
To measure the hand/finger position the House classification for the thumb in palm pattern will be assessed.
3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
MRI - Neurophysiological outcomes
Time Frame: 2 assessments: baseline, after the treatment (5 weeks)

Magnetic resonance imaging (MRI) of the brain will be conducted in a 3-T scanner, lasting approximately one hour (including preparation). Structural (T1-weighted and T2-weighted) and FLAIR imaging will be performed. Resting-state functional MRI (rs-fMRI) will be used to study the spontaneous fluctuations in blood oxygen level dependent (BOLD) signal.

Arterial spin labelling will be performed to assess blood flow imbalance.
2 assessments: baseline, after the treatment (5 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Insel Gruppe AG, University Hospital Bern

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Bern

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Regula Everts, Prof. Dr., Insel Gruppe AG, University Hospital Bern
  • Principal Investigator: Grunt Sebastian, Prof. Dr., Insel Gruppe AG, University Hospital Bern
  • Study Chair: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-00982

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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