Priming Effects of Ultra-high Frequency Quattro Pulse Transcranial Brain Stimulation Prior to Hand Motor Function Training in Children With Unilateral Spastic Cerebral Palsy

Last updated: April 22, 2024
Sponsor: Technical University of Munich
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Palsy

Limb Spasticity

Cataplexy

Treatment

Quadri-pulse theta burst stimulation

Clinical Study ID

NCT05165472
TRA-MAL-0034-I
  • Ages 6-18
  • All Genders

Study Summary

Unilateral spastic cerebral palsy (USCP) leads to life-long impairment with a hemiparesis of the affected side of the body. Rehabilitation efforts combine evidence based methods such as constrained induced movement therapy (CIMT) or hand-arm bimanual intensive therapy (HABIT) as well as training in daily life activities and psychological support in order to improve participation. It has been tried to enhance hand motor function trainings with non-invasive brain stimulation. However, evidence of this promising approach is limited. This might be due to a non-consideration of the individually different types of cortico-spinal projections to the paretic hand that demonstrated to be of highly relevant for the therapy of these children. Approximately one third of such patients control their paretic hands via crossed projections from the affected hemisphere (CONTRA), while one third uses ipsilateral projections from the contralesional hemisphere (IPSI). This study aims - for the first time - to enhance the effects of the training by priming the primary motor cortex (M1) of the paretic hand with a newly established high frequency quadri-pulse theta burst stimulation (qTBS) in a randomized, patient and evaluator blind, sham-controlled approach, for the first time taking the individual type of cortico-spinal reorganization (CONTRA vs IPSI) into account. This promising and neurophysiologically motivated approach is likely to ameliorate hand function in children with USCP.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Assured diagnosis of USCP.
  2. Children aged 6 to 18 years with USCP
  3. Dated and signed informed consent of legal guardian, informed assent from minor

Exclusion

Exclusion Criteria:

  1. Therapy refractory epilepsy
  2. Seizures within the last 2 years
  3. More than 1 anti epileptic drugs
  4. Implanted shunt system
  5. If singular primary motor cortex cannot be identified by TMS, e.g. because ofbilateral cortico-spinal reorganization or resting motor threshold above 80% maximumstimulator output (MSO)
  6. Severe mental retardation
  7. Psychiatric diseases
  8. Pregnancy
  9. Uncooperative patients

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: Quadri-pulse theta burst stimulation
Phase:
Study Start date:
July 01, 2022
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Technical University Munich

    Munich, 81377
    Germany

    Active - Recruiting

  • Clinic for Neuropediatrics and Neurorehabilitation, Epilepsy Center for Children and Adolescents, Schön Klinik

    Vogtareuth, 83569
    Germany

    Active - Recruiting

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