RecruitingNot ApplicableNCT05165472

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


Sponsor

Technical University of Munich

Enrollment

32 participants

Start Date

Jul 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 YearsMax Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria9

  • Therapy refractory epilepsy
  • Seizures within the last 2 years
  • More than 1 anti epileptic drugs
  • Implanted shunt system
  • If singular primary motor cortex cannot be identified by TMS, e.g. because of bilateral cortico-spinal reorganization or resting motor threshold above 80% maximum stimulator output (MSO)
  • Severe mental retardation
  • Psychiatric diseases
  • Pregnancy
  • Uncooperative patients

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Interventions

OTHERQuadri-pulse theta burst stimulation

High frequency transcranial quadri-pulse theta burst stimulation prior to hand motor function training


Locations(2)

Technical University Munich

Munich, Germany

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

Vogtareuth, Germany

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NCT05165472


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