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

Sponsor
Technische Universität München (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05165472
Collaborator
German Federal Ministry of Education and Research (Other)
32
2
36

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Quadri-pulse theta burst stimulation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, sham-controlled, patient- and evaluator-blind, two-centre, parallel group studyRandomized, sham-controlled, patient- and evaluator-blind, two-centre, parallel group study
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Real transcranial magnetic stimulation applied

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

Sham Comparator: Sahm-control

Sham transcranial magnetic stimulation applied

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

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Corticospinal reorganization [1 year]

    Subgroup analyses of the primary endpoint (cortico-spinal organization, age and sex) will be computed.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. Jebsen Taylor test [1 year]

    Differences of unimanual capacity (Jebsen-Taylor-Test) between the TMS and sham-TMS group between baseline and visit 12 as well as after 12 months follow-up.

  7. 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.

  8. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 18 Years
Sexes Eligible for Study:
All
Accepts 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. Epilepsy

  2. Implanted shunt system

  3. 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)

  4. Chronic medication acting on the central nervous system

  5. Severe mental retardation

  6. Psychiatric diseases

  7. Pregnancy

  8. Uncooperative patients

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Technische Universität München
  • German Federal Ministry of Education and Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT05165472
Other Study ID Numbers:
  • TRA-MAL-0034-I
First Posted:
Dec 21, 2021
Last Update Posted:
Jun 15, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Technische Universität München
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2022