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EXOPULSE Mollii Suit & Cerebral Palsy

NCT06266286 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-02-20

No results posted yet for this study

Summary

Spasticity is a frequent and debilitating symptom in patients with cerebral palsy. It can alter the patients' balance, mobility, as well as their quality of life (QoL). The available therapeutic strategies for treating spasticity and related symptoms are usually faced with limited efficacy and numerous side effects. For these reasons, non-invasive stimulation techniques, namely transcutaneous electric nerve stimulation using EXOPULSE Mollii suit, might be of help in this context.

Conditions

  • Cerebral Palsy

Interventions

DEVICE

EXOPULSE MOLLII SUIT (active)

Exopulse Mollii suit is a new assistive device that has been developed by Exoneural Network (initially Inerventions AB), a Swedish med-tech company. Exopulse Mollii suit is a full-body garment with integrated 58 electrodes that can transcutaneously stimulate several groups of muscles. This stimulation is not intended to obtain a motor effect (contraction of the muscles in question), but rather to decrease the spasticity in spastic muscles by activating the antagonistic muscles via the physiological mechanism of reciprocal inhibition. The device is CE labelled and is intended to use for reducing spasticity and improving blood circulation. The outfit is very easy to put on, it can be used for one hour every day and the analgesic effects last 24 hours or more

DEVICE

EXOPULSE MOLLII SUIT (sham)

In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off

Sponsors & Collaborators

  • Institut De La Colonne Vertebrale Et Des Neurosciences

    lead OTHER

Principal Investigators

  • Samar S AYACHE, MD, PhD · Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-13
Primary Completion
2025-06-30
Completion
2025-10-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06266286 on ClinicalTrials.gov