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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cerebral Palsy, Spastic Transcranial Magnetic Stimulation, Repetitive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intervention

Real transcranial magnetic stimulation applied

Group Type EXPERIMENTAL

Quadri-pulse theta burst stimulation

Intervention Type OTHER

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

Sahm-control

Sham transcranial magnetic stimulation applied

Group Type SHAM_COMPARATOR

Quadri-pulse theta burst stimulation

Intervention Type OTHER

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

Interventions

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Quadri-pulse theta burst stimulation

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No