Lateral Cord Magnetic Stimulation For Refractory Spastic Cerebral Palsy - Multicenter Double Blind Randomized and Controlled Trial

Who is this study for? Patients with refractory spastic cerebral palsy
What treatments are being studied? Magnetic Spinal Stimulation
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

Lateral cord stimulation (LCS) was discovered by the author as the producer of an average threshold increase for abnormal muscle contraction responses, in experimental pathological conditions, as described and referred. This physiological effect is proposed to improve tone, motor function and speech, in patients with spasticity of different causes, such as cerebrovascular accident, congenital brain malformations, perinatal anoxia (image called cerebral palsy), sequels of neurosurgery, etc. Due to its non-invasiveness and possible efficacy, the use of magnetic stimulation is proposed to try to demonstrate its therapeutic utility. This is the clinical test of phase 2/3 of the method, in the future, and how its use could be extended, if the results were positive, its indications could be extended to other pathological conditions, giving a greater spectrum of spastic patients, potentially benefited

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 50
Healthy Volunteers: f
View:

• Age 16 years or older.

• Spastic Cerebral Palsy with stable condition.

• Motor disability unilateral or predominantly unilateral.

• Clinically evident speech disorders.

• Normal or slightly subnormal intellectual coefficient (I.Q 80 or more)

• Absence of psychiatric disorders

Locations
Other Locations
Argentina
Centro de Rehabilitación San Juan de Dios
RECRUITING
Hurlingham
Contact Information
Primary
Juan Carlos M Andreani, MD
jcmandreani@gmail.com
0111550531392
Time Frame
Start Date: 2024-11-18
Estimated Completion Date: 2026-03-26
Participants
Target number of participants: 20
Treatments
Active_comparator: Treated Arm: Magnetic Spinal Stimulation plus PKT
Three months of kinesthetic and phoniatric treatment, and Magnetic Spinal Stimulation, 80% of the cervical muscles's motor threshold, 100 pulses at 10Hz, lasting 10 seconds, repeated during 30 minutes, twice a week for 3 months on cervical lateral location, focalized on the Lateral Spinal Cord.
Placebo_comparator: Sham comparator
They will receive kinesthetic and phoniatric treatment, and during 3 months,with equal periodicity, they will receive a sensible false magnetic stimulation, of equal localization that other arm, with insufficient intensity, to blind clinical experience.
Sponsors
Leads: Sociedad Argenttina de Neuromodulación
Collaborators: Provincial Perogram of Neuromodulation (Pcia Buenos Aires) Argentina, Hospital San Juan de Dios - Hurlingham - Argentina

This content was sourced from clinicaltrials.gov