Cerebral PalsyNCT02518867
Motor Disability of Children With Cerebral Palsy Using Motor Transcranial Magnetic Stimulation
A study testing high intensity iTBS and low intensity iTBS in people with Cerebral Palsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Transcranial magnetic stimulation (TMS) has opened new potential avenues for the treatment of neuropsychiatric diseases via the effects of modulation on neuroplasticity. Repetitive TMS (rTMS) is a non-invasive method of stimulation neural pathways in the brain of conscious subjects through the intact scalp. Read more about this study
- Who is it for?
- Ages 7 to 20 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- high intensity iTBS and low intensity iTBS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2013to Dec 2015
- 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 7 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosis of mild to moderate CP with spastic diplegia or hemiplegia according to clinical criteria
- age 7-20 years
- no use of botulinum toxin in the past 4 months
- no significant perceptual or communication disturbances
- no other peripheral or central nervous system dysfunction
- no active inflammatory or pathologic changes in lower limb joints during the previous 6 months
Show all 9Show fewer
- no active medical problems, such as pneumonia, upper gastrointestinal bleeding, or urinary tract infection
- no active problems of epilepsy and EEG without epileptiform discharge
- ability to walk 20m without walking aids, such as a cane, quadricane or walker
Who cannot join
- Metabolic disorders, such as inborn error of metabolism, electrolyte, and endocrine disorders.
- Active infectious disease, such as meningitis and encephalitis.
- Patients with active medical problems, such as pneumonia, upper gastrointestinal bleeding, or urinary tract infection.
- Poor compliance or intolerance for the TMS therapy
- Subjects with metallic implants or pregnancy.
- EEG show epileptiform discharge
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 333
Kuang-Lin Lin, +886-3-3281200 ext. 8200, lincgh@cgmh.org.tw
Kuang-Lin Lin
About this study
Official title: Modulating and Managing the Motor Disability of Children With Cerebral Palsy Using Motor Transcranial Magnetic Stimulation
Transcranial magnetic stimulation (TMS) has opened new potential avenues for the treatment of neuropsychiatric diseases via the effects of modulation on neuroplasticity. Repetitive TMS (rTMS) is a non-invasive method of stimulation neural pathways in the brain of conscious subjects through the intact scalp. The investigators hypothesize that excitatory rTMS applied over the motor cortex would increase motor cortex activity and result in an increase in the inhibitory input through the corticospinal tract to the spinal cord, thus reducing alpha neuron hyperactivity and consequently clinical spasticity. In this study, the investigators will apply the stimulation on the legs motor cortex area, which can cover supplemental motor area (SMA). Therefore, not only the spasticity, but also the motor control of legs both can be modulated by stimulation. Theta burst stimulation is a condition of rTMS which was designed by the co-investigator. It has controllable, consistent, long-lasting, and powerful effects on motor cortex physiology and behavior. The investigators therefore design this protocol using theta burst stimulation on the motor cortex of the patients of cerebral palsy. The investigators expect that there would be an effect on the reduction of spasticity after rTMS on the brain of children with CP, thus improving the motor control of legs.
Read the detailed description
In this study, the investigators design 3 steps to find out the optimal condition of rTMS for the treatment and managing of motor disability of CP. The first is to find out the optimal intensity of rTMS. The second is to find out the optimal duration of rTMS and long term effects. The third is to compare the effectiveness of botulinum toxin injection, rTMS, and combined therapy (botulinum toxin injection and rTMS) for children with CP.
- Conditions
- Cerebral Palsy
- Being tested
- high intensity iTBS, low intensity iTBS, sham iTBS
- Keywords
- Cerebral palsy, Transcranial magnetic stimulation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensity iTBSOther
Also called high intensity intermittent theta burst stimulation
In intermittent theta burst stimulation pattern (iTBS) will intermittently give a 2 s train of TBS every 10s for a total of 20 times (high intensity , 100% of active motor threshold) TBS for 3 days.
low intensity iTBSOther
Also called low intensity intermittent theta burst stimulation
In intermittent theta burst stimulation pattern (iTBS) will intermittently give a 2 s train of TBS every 10s for a total of 20 times (low intensity, 80% of active motor threshold) TBS for 3 days.
sham iTBSOther
Also called sham theta burst stimulation
In sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment.
| Study group | Role | What they receive |
|---|---|---|
| high intensity iTBS | Experimental | high intensity iTBS: 100% of active motor threshold for 3 days. Receives: Other: high intensity iTBS |
| low intensity iTBS | Experimental | low intensity iTBS: 80% of active motor threshold for 3 days. Receives: Other: low intensity iTBS |
| sham iTBS | Sham comparator | sham iTBS for 3 days. Receives: Other: sham iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of Kinematic analysis in post-treatment (after 3 days intervention) and one months follow up.
Kinematic analysis for gait analysis.
Measured: baseline, post-treatment (after 3 days intervention), one months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startMar 2013
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuang-Lin Lin, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518867
- Sponsor's protocol ID
- 98-0118A
- Status last verified
- Jul 2015
- First submitted
- 10 Feb 2015
- Last updated
- 10 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating and Managing the Motor Disability of Children With Cerebral Palsy Using Motor Transcranial Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT02518867
- Acronym / sponsor ID
- 98-0118A
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 10 Aug 2015 (estimated)
- 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.
Transcranial magnetic stimulation (TMS) has opened new potential avenues for the treatment of neuropsychiatric diseases via the effects of modulation on neuroplasticity. Repetitive TMS (rTMS) is a non-invasive method of stimulation neural pathways in the brain of conscious subjects through the intact scalp. The investigators hypothesize that excitatory rTMS applied over the motor cortex would increase motor cortex activity and result in an increase in the inhibitory input through the corticospinal tract to the spinal cord, thus reducing alpha neuron hyperactivity and consequently clinical spasticity. In this study, the investigators will apply the stimulation on the legs motor cortex area, which can cover supplemental motor area (SMA). Therefore, not only the spasticity, but also the motor control of legs both can be modulated by stimulation. Theta burst stimulation is a condition of rTMS which was designed by the co-investigator. It has controllable, consistent, long-lasting, and powerful effects on motor cortex physiology and behavior. The investigators therefore design this protocol using theta burst stimulation on the motor cortex of the patients of cerebral palsy. The investigators expect that there would be an effect on the reduction of spasticity after rTMS on the brain of children with CP, thus improving the motor control of legs.
Detailed description
In this study, the investigators design 3 steps to find out the optimal condition of rTMS for the treatment and managing of motor disability of CP. The first is to find out the optimal intensity of rTMS. The second is to find out the optimal duration of rTMS and long term effects. The third is to compare the effectiveness of botulinum toxin injection, rTMS, and combined therapy (botulinum toxin injection and rTMS) for children with CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high intensity iTBS | Experimental | Other: high intensity iTBShigh intensity iTBS: 100% of active motor threshold for 3 days. |
| low intensity iTBS | Experimental | Other: low intensity iTBSlow intensity iTBS: 80% of active motor threshold for 3 days. |
| sham iTBS | Sham comparator | Other: sham iTBSsham iTBS for 3 days. |
Who may qualify
- Ages
- 7 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- diagnosis of mild to moderate CP with spastic diplegia or hemiplegia according to clinical criteria
- age 7-20 years
- no use of botulinum toxin in the past 4 months
- no significant perceptual or communication disturbances
- no other peripheral or central nervous system dysfunction
Key exclusion criteria (6 listed)
- Metabolic disorders, such as inborn error of metabolism, electrolyte, and endocrine disorders.
- Active infectious disease, such as meningitis and encephalitis.
- Patients with active medical problems, such as pneumonia, upper gastrointestinal bleeding, or urinary tract infection.
- Poor compliance or intolerance for the TMS therapy
- Subjects with metallic implants or pregnancy.
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 |
|---|---|---|
| high intensity iTBSAlso: high intensity intermittent theta burst stimulationIn intermittent theta burst stimulation pattern (iTBS) will intermittently give a 2 s train of TBS every 10s for a total of 20 times (high intensity , 100% of active motor threshold) TBS for 3 days. | Other | high intensity iTBS |
| low intensity iTBSAlso: low intensity intermittent theta burst stimulationIn intermittent theta burst stimulation pattern (iTBS) will intermittently give a 2 s train of TBS every 10s for a total of 20 times (low intensity, 80% of active motor threshold) TBS for 3 days. | Other | low intensity iTBS |
| sham iTBSAlso: sham theta burst stimulationIn sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment. | Other | sham iTBS |
Primary outcome
Change from baseline of Kinematic analysis in post-treatment (after 3 days intervention) and one months follow up.
Time frame: baseline, post-treatment (after 3 days intervention), one months
Kinematic analysis for gait analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2015.
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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.
Kuang-Lin Lin study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high intensity iTBS and low intensity iTBS in people with Cerebral Palsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 9 inclusion and 6 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 10 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 Kuang-Lin Lin (+886-3-3281200 ext. 8200, lincgh@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of Kinematic analysis in post-treatment (after 3 days intervention) and one months follow up. (time frame: baseline, post-treatment (after 3 days intervention), one months). 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 10 Aug 2015.