Cerebral Palsy, Spastic, Transcranial Magnetic Stimulation, Repetitive
Conditions
Keywords
Unilateral Spastic Cerebral Palsy, Cortico-spinal Reorganization, Transcranial Magnetic Stimulation, Sham-controlled Trial, Intensive Hand Function Training
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.
Interventions
OTHERQuadri-pulse theta burst stimulation
High frequency transcranial quadri-pulse theta burst stimulation prior to hand motor function training
Sponsors
German Federal Ministry of Education and Research
Technical University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized, sham-controlled, patient- and evaluator-blind, two-centre, parallel group study
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assisting hand assessment | 10 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assisting hand assessement - smallest detectable difference | 1 year | Number of patients per treatment group who achieved the smallest detectable difference in logit assisting hand assessment score of 5 points at visit 12. |
| Assisting hand assessement - Follow up | 1 year | Difference in the assisting hand assessment logit score between the TMS and sham-TMS group 12 months after the standardized hand motor function training. |
| Neuronal plasticity | 1 year | 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. |
| Corticospinal reorganization | 1 year | Subgroup analyses of the primary endpoint (cortico-spinal organization, age and sex) will be computed. |
| Goal attainment scaling | 1 year | 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. |
| Canadian occupational performance measure | 1 year | 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. |
| Box-and-blocks test | 1 year | 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 |
Countries
Germany
Contacts
Primary ContactVolker Mall, Prof.
Backup ContactNikolai Jung, PD Dr. med
Outcome results
None listed