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

NCT05198921 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-09-19

No results posted yet for this study

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

Interventions

DEVICE

repetitive Transcranial Magnetic Stimulation

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

DEVICE

sham repetitive Transcranial Magnetic Stimulation

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

Sponsors & Collaborators

  • Universitat de Lleida

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2025-05-31
Completion
2025-06-30

Countries

  • Spain

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 NCT05198921 on ClinicalTrials.gov