Clinical trial NCT06536634: Effects and Mechanisms of Sensory Afferent Electrostimulation on Upper Limb Function in Patients With Hemiparesis
Official title: Effects and Mechanisms of Sensory Afferent Electrostimulation on Upper Limb Function in Patients With Hemiparesis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemiparesis
Unilateral Cerebral Palsy
Keywords: Sensory afferent electrostimulation
MRI
TMS
Motor function
Sensory function
Sensor
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2024-08-05
Enrollment: 34
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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)

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of hemiparesis
* Upper limb deficits.
* Written informed consent by participant and / or parent.

Exclusion criteria:

* Botulinum toxin injections in the last 6 months
* Hand surgery in the last 2 years
* UL trauma in the last year, medical conditions preventing UL training
* Participation in another UL training.

For children who additionally undergo MRI and TMS measurements, the exclusion criteria contain MRI or TMS or contraindications such as implanted metal and an active epilepsy.

Primary outcomes:
measure: Bimanual hand function
timeFrame: 5 weeks (After the treatment)
Secondary outcomes:
measure: Bimanual hand function
timeFrame: 2 assessments: baseline, follow up (12 weeks)
measure: Bimanual hand function in everyday life activities
timeFrame: 2 assessments: baseline, follow up (12 weeks)
measure: Spasticity
timeFrame: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
measure: Strength
timeFrame: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
measure: Sensitivity
timeFrame: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
measure: Sensitivity
timeFrame: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
measure: Unimanual hand function
timeFrame: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
measure: Stereognosis
timeFrame: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
measure: Hand function during daily activities
timeFrame: 2 assessments: baseline, after the treatment (5 weeks)
measure: Mirror movements
timeFrame: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
measure: Upper limb kinematic activity
timeFrame: 2 assessments: baseline, after the treatment (5 weeks)
measure: MRI - Neurophysiological outcomes
timeFrame: 2 assessments: baseline, after the treatment (5 weeks)
measure: TMS - Neurophysiological outcomes
timeFrame: 2 assessments: baseline, after the treatment (5 weeks)
measure: Quality of life of Children with hemiparesis
timeFrame: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
measure: Quality of life of Children with hemiparesis regarding hand function
timeFrame: 3 assessments: baseline, after the treatment (5 weeks), follow up (12 weeks)
measure: Reported Pain
timeFrame: Daily during the treatment phase (duration of treatment phase 5 weeks)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Regula Everts, Prof. Dr.
role: STUDY_CHAIR
affiliation: Insel Gruppe AG, University Hospital Bern
name: Grunt Sebastian, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: ARTORG
name: Nef Tobias, Prof. Dr.
role: STUDY_CHAIR
affiliation: Insel Gruppe AG, University Hospital Bern
name: Wiest Roland, Prof. Dr.
role: STUDY_CHAIR
affiliation: Insel Gruppe AG, University Hospital Bern
name: Seidel Kathleen, Prof. Dr.
role: STUDY_CHAIR
References: