Clinical trial NCT05165472: Priming Effects of Ultra-high Frequency Quattro Pulse Transcranial Brain Stimulation Prior to Hand Motor Function Training in Children With Unilateral Spastic Cerebral Palsy
Official title: Priming Effects of Ultra-high Frequency Quattro Pulse Transcranial Brain Stimulation Prior to Hand Motor Function Training in Children With Unilateral Spastic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy, Spastic
Transcranial Magnetic Stimulation, Repetitive
Keywords: Unilateral Spastic Cerebral Palsy
Cortico-spinal Reorganization
Transcranial Magnetic Stimulation
Sham-controlled Trial
Intensive Hand Function Training
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2021-12-21
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, sham-controlled, patient- and evaluator-blind, two-centre, parallel group study
Primary purpose: TREATMENT

Brief 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 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 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 of bilateral cortico-spinal reorganization or resting motor threshold above 80% maximum stimulator output (MSO)
6. Severe mental retardation
7. Psychiatric diseases
8. Pregnancy
9. Uncooperative patients

Primary outcomes:
measure: Assisting hand assessment
timeFrame: 10 days
Secondary outcomes:
measure: Corticospinal reorganization
timeFrame: 1 year
measure: Assisting hand assessement - smallest detectable difference
timeFrame: 1 year
measure: Assisting hand assessement - Follow up
timeFrame: 1 year
measure: Neuronal plasticity
timeFrame: 1 year
measure: Box-and-blocks test
timeFrame: 1 year
measure: Goal attainment scaling
timeFrame: 1 year
measure: Canadian occupational performance measure
timeFrame: 1 year
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Technical University Munich
city: Vogtareuth
country: Germany
facility: Clinic for Neuropediatrics and Neurorehabilitation, Epilepsy Center for Children and Adolescents, Schön Klinik
Study officials:
References: