Exopulse Mollii Suit, Motor Functions & CP Children With Cerebral Palsy

NCT05885139 | Unknown

• 1 other identifier: PS00011278C-001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

Cerebral Palsy (CP) is is estimated to be around 1.5-3 per live birth, with prenatal factors accounting for 75% of cases. CP appears in early childhood and persists with age and is characterized by permanent lesions or abnormalities affecting the immature brain. It mainly occurs as a motor system disorder (e.g., abnormal movements or posture) with the presence of hemiplegia, diplegia or tetraplegia, and spastic, dyskinetic or atactic syndromes. .This study will explore the potential clinical benefits of the Molliimethod in children with cerebral palsy. Spasticity impacts balance and mobility, halts the patients quality of life and their ability to perform their activity of daily living, and could also increase the risk of fractures and falls. Available interventions that aim on improving spasticity are facing limitations such as varios side effects. Therefore, developing novel therapies such as the EXOPULSE Mollii Suit could help to overcome such limitations and noninvasively improve balance, mobility, quality of life and reduce spasticity and pain in children with CP.

Conditions

Cerebral Palsy; Spasticity; Muscle; Pain Syndrome; Hemiplegia; Diplegia; Tetraplegia; Balance

Keywords

Exopulse; Mollii Suit; Spasticity; Neurostimulation

Outcome Measures

Primary Outcomes (1)

• Changes in Pediatric Balance Scale (PBS)

  Pediatric patients with CP, the PBS has a minimum detectable change (MDC) of 1.59 for the total score and 0.79 (static) and 0.96 (dynamic) for the subscores. Furthermore, the PBS has a minimally clinically important difference (MCID) for the cohort mentioned of 5.83 for the otal score and 2.92 (static) and 2.92 (dynamic) for the subscores.

  Visit 1 = Immediately before and after 1h stimulation; Visit 2 = 2 weeks after visit 1; Visit 3 = Immediately before and after 1h stimulation, 4 weeks after visit 1; Visit 4 = 6 weeks after visit 1

Secondary Outcomes (2)

• Changes in Modified Ashworth Scale (MAS)

  Visit 1 = Immediately before and after 1h stimulation; Visit 2 = 2 weeks after visit 1; Visit 3 = Immediately before and after 1h stimulation, 4 weeks after visit 1; Visit 4 = 6 weeks after visit 1

• Changes in Timed Up and Go (TUG)

  Visit 1 = Immediately before and after 1h stimulation; Visit 2 = 2 weeks after visit 1; Visit 3 = Immediately before and after 1h stimulation, 4 weeks after visit 1; Visit 4 = 6 weeks after visit 1

Other Outcomes (3)

• Patient Diary

  Visit 1; Visit 2 = 2 weeks after visit 1; Visit 3 = 4 weeks after visit 1. Visit 4 = 6 weeks after visit 1

• Blinding Questionnaire

  Visit 2 = 2 weeks after visit 1; Visit 4 = 6 weeks after visit 1

• Changes in Functional Gait Assessment (FGA)

  Visit 1 = Immediately before and after 1h stimulation; Visit 2 = 2 weeks after visit 1; Visit 3 = Immediately before and after 1h stimulation, 4 weeks after visit 1. ; Visit 4 = 6 weeks after visit 1

Study Arms (2)

Active Stimulation

ACTIVE COMPARATOR

Active sessions will last 1 hour of stimulation per day for 2 weeks. The following parameters will be used for electric stimulation: low frequency (20 Hz), low current intensity (2 mA), with a small pulse width of 25-170 microseconds.

Device: Exopulse Mollii Suit

Sham Stimulation

SHAM COMPARATOR

In the sham condition, subjects will be asked to wear the device for 1 hour per day for 2 weeks. During 1 hour use per day, the actual stimulation will last only 1 minute and then will shut off.

Device: Sham Exopulse Mollii Suit

Interventions

Exopulse Mollii Suit DEVICE

Exopulse Mollii suits consists of a body Garments (Jacket and Pants) and a control unit. The body Garments (Jacket and Pants) is a suit with 58 embedded electrodes that can stimulate 40 groups of muscles, conductive wires and connectors to a detachable control unit, whose intended purpose is to transmit electric pulses from the control unit to key nerves and corresponding muscle groups throughout the body. The control unit is a battery powered electrical device which sends low intensity electric pulses through connectors to the Body Garments which in turn transmits the pulses from the connectors to key nerves and corresponding muscle groups throughout the body.

Active Stimulation

Sham Exopulse Mollii Suit DEVICE

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

Sham Stimulation

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients will be included if they
• are between 5 and 12 years of age.
• have a clinical diagnosis of unilateraal or bilateral spastic CP by birth \[15\].
• have a PBS score between a minimum of 15 and a maxmimum of 44 points.
• are able to walk freely, with slight limitation or using ancillary equipment's (GMFCS score ≤3) \[49\].
• are German speakers, able to understand verbal instructions.
• have spasticity with a score of at least 1+ on the MAS

You may not qualify if:

• Patients will not be included if they
• are included in another research protocol during the study period.
• are unable to undergo clinical procedures for the study purposes due to geographical or social reasons.
• have a cardiac stimulator, a ventriculoperitoneal shunt, intrathecal baclofen pump.
• have a change in their pharmacological therapy over the last three months or are planning to do so during the study.
• suffer from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain).
• have a body mass index above 35 kg/m2,
• have contraindications to wearing Exopulse Mollii Suit, receive a medical device other than Exopulse Mollii during the study period.
• have received botulinum toxin (botox) therapy in the last 3 months before the start of the study

Sponsors & Collaborators

• Exoneural Network AB: lead
• Ottobock SE & Co. KGaA: collaborator
• Hannover Medical School: collaborator
• Pohlig GmbH: collaborator

Study Sites (2)

Pohlig GmbH

Traunstein, Bavaria, Germany

RECRUITING

Medizinische Hochschule Hannover (MHH)

Hanover, Germany

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity; Somatoform Disorders; Hemiplegia; Quadriplegia

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Paralysis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Active Comparator: Active Active sessions will last 1 hour each. The following parameters will be used for electric stimulation: low frequency (20 Hz), low current intensity (2 mA), with a small pulse width of 25-170 microseconds. Sham Comparator: Sham In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: June 1, 2023
• Study Start: April 17, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)