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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 18
Healthy Volunteers: f
View:

• Assured diagnosis of USCP.

• Children aged 6 to 18 years with USCP

• Dated and signed informed consent of legal guardian, informed assent from minor

Locations
Other Locations
Germany
Technical University Munich
RECRUITING
Munich
Clinic for Neuropediatrics and Neurorehabilitation, Epilepsy Center for Children and Adolescents, Schön Klinik
RECRUITING
Vogtareuth
Contact Information
Primary
Volker Mall, Prof.
volker.mall@kbo.de
+49 (0)89 71009-233
Backup
Nikolai Jung, PD Dr. med
nikolai.jung@tum.de
+49 (0)89 71009-236
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 32
Treatments
Experimental: Intervention
Real transcranial magnetic stimulation applied
Sham_comparator: Sahm-control
Sham transcranial magnetic stimulation applied
Related Therapeutic Areas
Sponsors
Leads: Technical University of Munich
Collaborators: German Federal Ministry of Education and Research

This content was sourced from clinicaltrials.gov