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

NCT05165472 | Recruiting

• 1 other identifier: TRA-MAL-0034-I
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Assisting hand assessment

  Difference in change of logit assisting hand assessment scores between the TMS and sham-TMS group from baseline to end of 10 days intensive hand function training.

  10 days

Secondary Outcomes (7)

• Corticospinal reorganization

  1 year

• Assisting hand assessement - smallest detectable difference

  1 year

• Assisting hand assessement - Follow up

  1 year

• Neuronal plasticity

  1 year

• Box-and-blocks test

  1 year

Study Arms (2)

Intervention

EXPERIMENTAL

Real transcranial magnetic stimulation applied

Other: Quadri-pulse theta burst stimulation

Sahm-control

SHAM COMPARATOR

Sham transcranial magnetic stimulation applied

Other: Quadri-pulse theta burst stimulation

Interventions

Quadri-pulse theta burst stimulation OTHER

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

Intervention; Sahm-control

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (2)

Technical University Munich

Munich, 81377, Germany

RECRUITING

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

Vogtareuth, 83569, Germany

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Volker Mall, Prof.

CONTACT

+49 (0)89 71009-233; volker.mall@kbo.de

Nikolai Jung, PD Dr. med

CONTACT

+49 (0)89 71009-236; nikolai.jung@tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, sham-controlled, patient- and evaluator-blind, two-centre, parallel group study

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 21, 2021
• Study Start: July 1, 2022
• Primary Completion: October 31, 2025
• Study Completion: March 31, 2026
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: The study protocol will be published in an international journal. Data will be available for other reseachers upon request.

Locations

DE (2)