HemiparesisSAESNCT06536634
Effects and Mechanisms of Sensory Afferent Electrostimulation on Upper Limb Function in Patients With Hemiparesis
A study testing SAES and TAU in people with Hemiparesis and Unilateral Cerebral Palsy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Hemiparesis, Unilateral Cerebral Palsy
- What is being tested?
- SAES and TAU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2025to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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 join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sebastian Grunt, Prof. Dr. contact
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital
Bern, 3010
Sebastian Grunt, Prof. Dr.
About this study
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.
Read more
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)
Read the 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.
- Conditions
- Hemiparesis, Unilateral Cerebral Palsy
- Being tested
- SAES, TAU
- Keywords
- Sensory afferent electrostimulation, MRI, TMS, Motor function, Sensory function, Sensor
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAESOther
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.
TAUOther
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| SAES | Experimental | Treatment group (SAES)
Interventions: Sensory afferent electrical stimulation (SAES) Receives: Other: SAES |
| Control group | Other | The control intervention (treatment as usual, TAU) consists of the prescribed conventional occupational therapy and/or physiotherapy. Receives: Other: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bimanual hand function
Will be measured with the Assisting Hand Assessment (AHA)
Measured: 5 weeks (After the treatment)
Secondary outcomes (17)
Bimanual hand function
Will be measured with the Assisting Hand Assessment (AHA)
Measured: 2 assessments: baseline, follow up (12 weeks)
Bimanual hand function in everyday life activities
Will be measured with the Chedoke Arm and Hand Activity Inventory (CAHAI)
Measured: 2 assessments: baseline, follow up (12 weeks)
Spasticity
Will be assessed via clinical assessments (Modified Ashworth scale)
Measured: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Strength
Will be assessed via clinical assessments (Dynamometer)
Measured: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Sensitivity
Will be assessed via clinical assessments (Semmes-Weinstein monofilaments)
Measured: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Unimanual hand function
Will be assessed via clinical assessments (Jebson-Taylor Hand function test)
Measured: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Stereognosis
Will be assessed via clinical assessments (Stereognosis test with Jamar toolkit)
Measured: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Hand function during daily activities
Will be assessed via questionnaires (CHEQ)
Measured: 2 assessments: baseline, after the treatment (5 weeks)
Mirror movements
Will be assessed via clinical assessments (Woods and Teuber Scale)
Measured: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Hand/wrist position
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.
Measured: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Hand/Finger position
To measure the hand/finger position the House classification for the thumb in palm pattern will be assessed.
Measured: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Upper limb kinematic activity
Will be assessed with novel sensory measures in an instrumented apartment using DeepLabCut software
Measured: 2 assessments: baseline, after the treatment (5 weeks)
MRI - Neurophysiological outcomes
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.
Measured: 2 assessments: baseline, after the treatment (5 weeks)
TMS - Neurophysiological outcomes
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.
Measured: 2 assessments: baseline, after the treatment (5 weeks)
Quality of life of Children with hemiparesis
Will be assessed via the Kidscreen-52 questionnaire, which was designed to address generic health related quality of life.
Measured: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Quality of life of Children with hemiparesis regarding hand function
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.
Measured: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
Reported Pain
Will be assessed via a visual analogue scale regarding the experienced pain on the paretic hand before and after the electrical stimulation.
Measured: Daily during the treatment phase (duration of treatment phase 5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Jan 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemiparesisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Regula Everts, Prof. Dr., Study chair, Insel Gruppe AG, University Hospital BernGrunt Sebastian, Prof. Dr., Principal investigator, Insel Gruppe AG, University Hospital BernNef Tobias, Prof. Dr., Study chair, ARTORGWiest Roland, Prof. Dr., Study chair, Insel Gruppe AG, University Hospital BernSeidel Kathleen, Prof. Dr., Study chair, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536634
- Sponsor's protocol ID
- 2024-00982
- Acronym
- SAES
- Status last verified
- Nov 2025
- First submitted
- 10 Jul 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gschaidmeier A, Lory K, Mori K, Moser A, Nef T, Seidel K, Simon-Martinez C, Von Gunten M, Wermelinger J, Wiest R, Everts R, Grunt S. Sensory afferent electrical stimulation to improve upper limb function in children with hemiparesis - a randomised controlled trial (SenseUp study protocol). Front Pediatr. 2026 Aug 12;14:1886291. doi: 10.3389/fped.2026.1886291. eCollection 2026.
PubMed 42656484
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Mechanisms of Sensory Afferent Electrostimulation on Upper Limb Function in Patients With Hemiparesis
- ClinicalTrials.gov ID
- NCT06536634
- Acronym / sponsor ID
- SAES / 2024-00982
- Conditions
- Hemiparesis, Unilateral Cerebral Palsy
- Keywords
- Sensory afferent electrostimulation, MRI, TMS, Motor function, Sensory function, Sensor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| SAES | Experimental | Other: SAESTreatment group (SAES) Interventions: Sensory afferent electrical stimulation (SAES) |
| Control group | Other | Other: TAUThe control intervention (treatment as usual, TAU) consists of the prescribed conventional occupational therapy and/or physiotherapy. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAESThe 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 | SAES |
| TAUTreatment as usual | Other | Control group |
Primary outcome
Bimanual hand function
Time frame: 5 weeks (After the treatment)
Will be measured with the Assisting Hand Assessment (AHA)
17 secondary outcomes
Bimanual hand function
Time frame: 2 assessments: baseline, follow up (12 weeks)
Bimanual hand function in everyday life activities
Time frame: 2 assessments: baseline, follow up (12 weeks)
Spasticity
Time frame: 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)
Sensitivity
Time frame: 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)
Stereognosis
Time frame: 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)
Mirror movements
Time frame: 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)
Hand/Finger position
Time frame: 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)
MRI - Neurophysiological outcomes
Time frame: 2 assessments: baseline, after the treatment (5 weeks)
TMS - Neurophysiological outcomes
Time frame: 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)
Quality of life of Children with hemiparesis regarding hand function
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Derived from this study: PubMed 42656484Gschaidmeier A, Lory K, Mori K, Moser A, Nef T, Seidel K, Simon-Martinez C, Von Gunten M, Wermelinger J, Wiest R, Everts R, Grunt S. Sensory afferent electrical stimulation to improve upper limb function in children with hemiparesis - a randomised controlled trial (SenseUp study protocol). Front Pediatr. 2026 Aug 12;14:1886291. doi: 10.3389/fped.2026.1886291. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sebastian Grunt, Prof. Dr. contact
Regula Everts, Prof. Dr. study chair
Insel Gruppe AG, University Hospital Bern
Grunt Sebastian, Prof. Dr. principal investigator
Insel Gruppe AG, University Hospital Bern
Nef Tobias, Prof. Dr. study chair
ARTORG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAES and TAU in people with Hemiparesis and Unilateral Cerebral Palsy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alisa Gschaidmeier, Dr. med. (031 632 94 24, alisa.gschaidmeier@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bimanual hand function (time frame: 5 weeks (After the treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06536634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.