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

Technical University of Munich

Status: Enrolling

Conditions: Transcranial Magnetic Stimulation, Repetitive; Cerebral Palsy, Spastic

Treatments: Other: Quadri-pulse theta burst stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05165472

TRA-MAL-0034-I

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

32 participants in 2 patient groups

Intervention

Experimental group

Description:

Real transcranial magnetic stimulation applied

Treatment:

Other: Quadri-pulse theta burst stimulation

Sahm-control

Sham Comparator group

Description:

Sham transcranial magnetic stimulation applied

Treatment:

Other: Quadri-pulse theta burst stimulation