The Effectiveness of Repetitive Transcranial Magnetic Stimulation for Spastic Diplegia Cerebral Palsy

NCT05198921 | Not Yet Recruiting DMC

• 1 other identifier: ULleida1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral palsy describes a group of permanent disorders of the development of movement and posture, causing activity limitation that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain. Nowadays, CP is not fully curable, and physiotherapy should be used in conjunction with other interventions such as oral drugs, botulinum toxin type A, continuous pump-administered intrathecal baclofen, orthopaedic surgery and selective dorsal rhizotomy. However, several systematic reviews conclude that there is low evidence that these invasive therapies are more effective than placebo. Repetitive transcranial magnetic stimulation (rTMS) is a type of neuromodulatory technique through magnetic impulses. The effect of rTMS depends on the frequency of the emitted electromagnetic field; low frequencies (≤1 Hz) lead to an inhibition of neuronal electrical activity at the stimulation site, while high frequencies (≥3 Hz) cause neuronal depolarization. The objective of the project is to evaluate the effectiveness of a repetitive Transcranial Magnetic Stimulation (rTMS) protocol, as an adjunct treatment to neurorehabilitation to improve gross motor function and quality of life in school-age children with spastic diplegia-type infantile cerebral palsy.

Conditions

Cerebral Palsy, Spastic

Outcome Measures

Primary Outcomes (1)

• Change in Gross Motor Function by the Gross Motor Function-66

  The GMFM is a standardized assessment instrument designed to measure change over time in gross motor function in cerebral palsy children. The GMFS-66 is an 66-item measure with five dimensions: lying and rolling, crawling/kneeling, standing and walking/running/jumping. Each GMFM item is graded on a 4-point scale. The magnitude of change that is considered clinically important for an individual child will vary and depend on the judgments made by the child, family, and therapist. It takes between 20-25 minutes to be completed. GMFM presents good longitudinal construct validity, the test - retest is high with a 0.99 ICC and researchers indicate that GMFM adequately measure change over time in gross motor function for children with CP.

  baseline, one month, two months, three months and six months.

Secondary Outcomes (5)

• Change in Functional Strength by the Functional Strength Measure

  baseline, one month, two months, three months and six months.

• Change in Quality of Life by the Cerebral Palsy Quality of Life-Child

  baseline, one month, two months, three months and six months.

• Change in Spasticity by the Modified-Modified Ashworth Scale.

  baseline, one month, two months, three months and six months.

• Change in Impact on family by the Revised Impact on Family questionnaire

  baseline, one month, two months, three months and six months.

• Cortex excitability

  Enrollment, 1st month, 2nd month, 3rd month and 4th month

Study Arms (2)

rTMS + neurorehabilitation

EXPERIMENTAL

Device: repetitive Transcranial Magnetic Stimulation; Device: sham repetitive Transcranial Magnetic Stimulation

sham rTMS + neurorehabilitation

SHAM COMPARATOR

Device: repetitive Transcranial Magnetic Stimulation; Device: sham repetitive Transcranial Magnetic Stimulation

Interventions

repetitive Transcranial Magnetic Stimulation DEVICE

To apply the rTMS will be used the device Neuro-MS/D Variant-3 therapeutic advanced (Neurosoft, Russia) with double cone shape coil. The coil will be placed at Cz according to 10-20 system. The rTMS protocol will be: Train frequency - 10 Hz Train duration - 10 sec Inter train interval - 50 seconds Number of train - 25 \------------------------------------- Total pulses - 2500 Total session duration - 1500 seconds

rTMS + neurorehabilitation; sham rTMS + neurorehabilitation

sham repetitive Transcranial Magnetic Stimulation DEVICE

Neuro-MS/D magnetic stimulator (Neurosoft, Russia) with Neuro-MS.NET software will be used. The synchronous sound will be performed using monitor speaker connected to magnetic stimulator via trigger unit and located near discharging coil. The 10-Hz electrical stimulation will be given trough electrodes fixed on the head along the front edge of the coil to mimic the sensation

rTMS + neurorehabilitation; sham rTMS + neurorehabilitation

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Primary school children with diagnose of Spastic Diplegia CP
• \> 1 on Mas in hip flexors, adductors and tibialis anterior of both lower extremities.
• Parents/legal guardians signed the Informed consent

You may not qualify if:

• Severe mental retardation
• Present epilepsy
• Present any remedial surgery/medication
• Less than 1 year post orthopaedic surgery
• Less than 6 months post botulinum toxin type A injection
• Present metallic implants
• Present any comorbidity unfit for the study
• Congenital disorders such as Down's syndrome, fragile-x syndrome or congenital anomalies

Sponsors & Collaborators

• Universitat de Lleida: lead

Study Sites (1)

Claudia Arumi

Lleida, Lleida, 25006, Spain

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

CLAUDIA ARUMI, Msc

CONTACT

34+630-00-47-67; claudia.arumi@udl.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized crossover double-blind trial. It is a pre-post study with follow-up at 1 month

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 20, 2022
• Study Start: January 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)