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NCT Number: NCT06536634

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

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)

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inselspital

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Sebastian Grunt, Prof. Dr.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

TAU

Other

Treatment as usual

Primary outcomes

  1. Bimanual hand function

    Time frame: 5 weeks (After the treatment)

    Will be measured with the Assisting Hand Assessment (AHA)

Secondary outcomes

  1. Bimanual hand function

    Time frame: 2 assessments: baseline, follow up (12 weeks)

    Will be measured with the Assisting Hand Assessment (AHA)

  2. 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)

  3. Spasticity

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

    Will be assessed via clinical assessments (Modified Ashworth scale)

  4. Strength

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

    Will be assessed via clinical assessments (Dynamometer)

  5. Sensitivity

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

    Will be assessed via clinical assessments (Semmes-Weinstein monofilaments)

  6. 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)

  7. 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)

  8. Hand function during daily activities

    Time frame: 2 assessments: baseline, after the treatment (5 weeks)

    Will be assessed via questionnaires (CHEQ)

  9. 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)

  10. 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.

  11. 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.

  12. 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

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alisa Gschaidmeier, Dr. med.

CONTACT

[email protected]

031 632 94 24

Sebastian Grunt, Prof. Dr.

CONTACT

031 632 94 24

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • University of Bern

Registry information

Acronym: SAES

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2024
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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