Cerebral Palsy, SpasticTRAINCPNCT05165472
Priming Effects of Ultra-high Frequency Quattro Pulse Transcranial Brain Stimulation Prior to Hand Motor Function Training in Children With Unilateral Spastic Cerebral Palsy
A study testing Quadri-pulse theta burst stimulation in people with Cerebral Palsy, Spastic and Transcranial Magnetic Stimulation, Repetitive, run by Technical University of Munich at 2 sites in Germany.
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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy, Spastic, Transcranial Magnetic Stimulation, Repetitive
- What is being tested?
- Quadri-pulse theta burst stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jul 2022to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Assured diagnosis of USCP.
- Children aged 6 to 18 years with USCP
- Dated and signed informed consent of legal guardian, informed assent from minor
Who cannot join
- Therapy refractory epilepsy
- Seizures within the last 2 years
- More than 1 anti epileptic drugs
- Implanted shunt system
- 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)
- Severe mental retardation
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- Psychiatric diseases
- Pregnancy
- Uncooperative patients
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Technical University Munich
Munich, 81377
Volker Mall, Prof., +49 (0)89 71009-233, volker.mall@kbo.de
Nikolai Jung, Dr., +49 (0)89 71009-236, nikolai.jung@tum.de
- Recruiting
Clinic for Neuropediatrics and Neurorehabilitation, Epilepsy Center for Children and Adolescents, Schön Klinik
Vogtareuth, 83569
Steffen Berweck, Prof., +49 (0)8038 901418, sberweck@schoen-kliniken.de
Julia Hartmann, +49 (0)8038 901418, JHartmann@schoen-klinik.de
About this study
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.
- Being tested
- Quadri-pulse theta burst stimulation
- Keywords
- Unilateral Spastic Cerebral Palsy, Cortico-spinal Reorganization, Transcranial Magnetic Stimulation, Sham-controlled Trial, Intensive Hand Function Training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadri-pulse theta burst stimulationOther
High frequency transcranial quadri-pulse theta burst stimulation prior to hand motor function training
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Real transcranial magnetic stimulation applied Receives: Other: Quadri-pulse theta burst stimulation |
| Sahm-control | Sham comparator | Sham transcranial magnetic stimulation applied Receives: Other: Quadri-pulse theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days
Secondary outcomes (7)
Corticospinal reorganization
Subgroup analyses of the primary endpoint (cortico-spinal organization, age and sex) will be computed.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 Jul 2022
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, sham-controlled, patient- and evaluator-blind, two-centre, parallel group study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165472
- Sponsor's protocol ID
- TRA-MAL-0034-I
- Acronym
- TRAINCP
- Status last verified
- Apr 2024
- First submitted
- 7 Dec 2021
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing upon request planned
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05165472
- Acronym / sponsor ID
- TRAINCP / TRA-MAL-0034-I
- Keywords
- Unilateral Spastic Cerebral Palsy, Cortico-spinal Reorganization, Transcranial Magnetic Stimulation, Sham-controlled Trial, Intensive Hand Function Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, sham-controlled, patient- and evaluator-blind, two-centre, parallel group study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Quadri-pulse theta burst stimulationReal transcranial magnetic stimulation applied |
| Sahm-control | Sham comparator | Other: Quadri-pulse theta burst stimulationSham transcranial magnetic stimulation applied |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Assured diagnosis of USCP.
- Children aged 6 to 18 years with USCP
- Dated and signed informed consent of legal guardian, informed assent from minor
Key exclusion criteria (9 listed)
- Therapy refractory epilepsy
- Seizures within the last 2 years
- More than 1 anti epileptic drugs
- Implanted shunt system
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadri-pulse theta burst stimulationHigh frequency transcranial quadri-pulse theta burst stimulation prior to hand motor function training | Other | Intervention, Sahm-control |
Primary outcome
Assisting hand assessment
Time frame: 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.
7 secondary outcomes
Corticospinal reorganization
Time frame: 1 year
Assisting hand assessement - smallest detectable difference
Time frame: 1 year
Assisting hand assessement - Follow up
Time frame: 1 year
Neuronal plasticity
Time frame: 1 year
Box-and-blocks test
Time frame: 1 year
Goal attainment scaling
Time frame: 1 year
Canadian occupational performance measure
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: Yes. Sharing upon request planned
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadri-pulse theta burst stimulation in people with Cerebral Palsy, Spastic and Transcranial Magnetic Stimulation, Repetitive, run by Technical University of Munich at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Volker Mall, Prof. (+49 (0)89 71009-233, volker.mall@kbo.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assisting hand assessment (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.