Cerebral PalsyNCT01852474
Effects of Transcranial Direct Current Stimulation (tDCS) and Motor Learning in Children With Cerebral Palsy (CP)
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Cerebral Palsy, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
In this study, the investigators aim to assess the clinical and neurophysiological effects of a non-invasive brain stimulation technique - transcranial direct current stimulation (tDCS)- on cortical plasticity and motor learning in children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to May 2016
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age of participants must be between 8 and 18 years old.
- Diagnosis of spastic or mixed CP with distribution of diplegia and/or hemiplegia form.
- Gross Motor Function Classification System for Cerebral Palsy (GMFCS) level II and III.
- Manual Ability Classification System for Children with CP (MACS) level II up to IV.
- Ability to cooperate and follow directions.
Who cannot join
- Muscle tone reduction therapy in the past 3 months prior to study onset.
- Upper limb orthopedic surgery in the past 3 months prior to study onset.
- Any other form of therapy or procedure involving motor neuron junction inhibition; either by biochemical and/or mechanical denervation, in the past 3 months prior to study onset.
- History of convulsive disorder in the past 2 years prior to study onset.
- Current use of carbamazepine as anticonvulsive therapy.
- Presence ventriculoperitoneal shunt.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Network Research Institute
Charlestown, Massachusetts, 02129
About this study
Official title: Effects of tDCS in Cortical Plasticity and Motor Learning in Children With Cerebral Palsy
In this study, the investigators aim to assess the clinical and neurophysiological effects of a non-invasive brain stimulation technique - transcranial direct current stimulation (tDCS)- on cortical plasticity and motor learning in children with cerebral palsy. Investigators will use different assessment techniques, such as transcranial magnetic stimulation (TMS) and kinematics (sensors) to measure changes through the trial.
- Conditions
- Cerebral Palsy
- Being tested
- Transcranial Direct Current Stimulation (tDCS)
- Keywords
- motor learning, cortical plasticity, direct current 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.
Transcranial Direct Current Stimulation (tDCS)Device
Also called 1x1 direct current stimulator, soterix medical, transcranial stimulation
Subjects will receive tDCS stimulation 1x per day for 5 days (over the period of 1 week). Each session will be 20 minutes long. The subject will receive active stimulation for the entire 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Subjects will receive active tDCS stimulation for 5 sessions (20m/each) over one week. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in motor assessments
Investigators will measure changes in kinematic (sensor) assessments from baseline to follow-up. The sensor will collect Inertial Measurements Units (IMU) and complex motion sensing, as measured by accelerometer/gyroscope/magnetometer of freedom motion capture.
Measured: Approximately 2 weeks
Secondary outcomes (1)
Changes in TMS measurements
Investigators will measure change in TMS measurements from baseline to follow-up. TMS measures will consist of: motor threshold, motor evoked potentials (MEP's), transcallosal inhibition, and examinations of intracortical inhibition and facilitation.
Measured: Approximately 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2016
- Study completionMay 2016
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pedal with Pete
- Responsible party
- Principal investigator, Felipe Fregni, Spaulding Rehabilitation Hospital
- Investigators
- Felipe Fregni, MD PhD MPH, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852474
- Sponsor's protocol ID
- 2012-p-000629
- Status last verified
- Apr 2020
- First submitted
- 8 May 2013
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of tDCS in Cortical Plasticity and Motor Learning in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT01852474
- Acronym / sponsor ID
- 2012-p-000629
- Conditions
- Cerebral Palsy
- Keywords
- motor learning, cortical plasticity, direct current stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Pedal with Pete
- Study start
- May 2013 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 13 May 2013 (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.
In this study, the investigators aim to assess the clinical and neurophysiological effects of a non-invasive brain stimulation technique - transcranial direct current stimulation (tDCS)- on cortical plasticity and motor learning in children with cerebral palsy. Investigators will use different assessment techniques, such as transcranial magnetic stimulation (TMS) and kinematics (sensors) to measure changes through the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Transcranial Direct Current Stimulation (tDCS)Subjects will receive active tDCS stimulation for 5 sessions (20m/each) over one week. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age of participants must be between 8 and 18 years old.
- Diagnosis of spastic or mixed CP with distribution of diplegia and/or hemiplegia form.
- Gross Motor Function Classification System for Cerebral Palsy (GMFCS) level II and III.
- Manual Ability Classification System for Children with CP (MACS) level II up to IV.
- Ability to cooperate and follow directions.
Key exclusion criteria (6 listed)
- Muscle tone reduction therapy in the past 3 months prior to study onset.
- Upper limb orthopedic surgery in the past 3 months prior to study onset.
- Any other form of therapy or procedure involving motor neuron junction inhibition; either by biochemical and/or mechanical denervation, in the past 3 months prior to study onset.
- History of convulsive disorder in the past 2 years prior to study onset.
- Current use of carbamazepine as anticonvulsive therapy.
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 |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)Also: 1x1 direct current stimulator, soterix medical, transcranial stimulationSubjects will receive tDCS stimulation 1x per day for 5 days (over the period of 1 week). Each session will be 20 minutes long. The subject will receive active stimulation for the entire 20 minutes. | Device | Active tDCS |
Primary outcome
Changes in motor assessments
Time frame: Approximately 2 weeks
Investigators will measure changes in kinematic (sensor) assessments from baseline to follow-up. The sensor will collect Inertial Measurements Units (IMU) and complex motion sensing, as measured by accelerometer/gyroscope/magnetometer of freedom motion capture.
1 secondary outcome
Changes in TMS measurements
Time frame: Approximately 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
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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.
Felipe Fregni, MD PhD MPH principal investigator
Spaulding Rehabilitation 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 Transcranial Direct Current Stimulation (tDCS) in people with Cerebral Palsy, run by Spaulding Rehabilitation Hospital at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 24 Apr 2020. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in motor assessments (time frame: Approximately 2 weeks). 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 24 Apr 2020.