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

Cerebral Palsy, Spastic Clinical Trial

— TRAINCP  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05165472
• Other study ID #: TRA-MAL-0034-I
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: April 2024
• Source: Technical University of Munich
• Contact: Volker Mall, Prof.
• Phone: +49 (0)89 71009-233
• Email: volker.mall[@]kbo.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: March 31, 2026
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Muscle Spasticity
• Paralysis
• Transcranial Magnetic Stimulation, Repetitive

Intervention

Other:
• Quadri-pulse theta burst stimulation
High frequency transcranial quadri-pulse theta burst stimulation prior to hand motor function training

Locations

Country	Name	City	State
Germany	Technical University Munich	Munich
Germany	Clinic for Neuropediatrics and Neurorehabilitation, Epilepsy Center for Children and Adolescents, Schön Klinik	Vogtareuth

Sponsors (2)

Lead Sponsor	Collaborator
Technical University of Munich	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Corticospinal reorganization	Subgroup analyses of the primary endpoint (cortico-spinal organization, age and sex) will be computed.	1 year
Secondary	Assisting hand assessement - smallest detectable difference	Number of patients per treatment group who achieved the smallest detectable difference in logit assisting hand assessment score of 5 points at visit 12.	1 year
Secondary	Assisting hand assessement - Follow up	Difference in the assisting hand assessment logit score between the TMS and sham-TMS group 12 months after the standardized hand motor function training.	1 year
Secondary	Neuronal plasticity	Differences in neuronal plasticity as measured by motor evoked potentials with suprathreshold TMS single pulses between baseline and visit 12 as well as after 12 months follow-up.	1 year
Secondary	Box-and-blocks test	Differences of Blocks transferred with the Box-and-blocks test between the TMS and sham-TMS group between baseline and visit 12 as well as after 12 months follow-up	1 year
Secondary	Goal attainment scaling	Differences in Goal Attainment Scaling between the TMS and sham-TMS group between baseline and visit 12 as well as after 12 months follow-up.	1 year
Secondary	Canadian occupational performance measure	Differences in the Canadian Occupational Performance Measure scale between the TMS and sham-TMS group between baseline and visit 12 as well as after 12 months follow-up.	1 year