Cerebral PalsyNCT03145532
Transcranial Direct-Current Stimulation (tCDS) and Robotics for Children With Hemiplegia
A study testing tDCS plus robotic training in people with Cerebral Palsy and Hemiplegia, run by Blythedale Children's Hospital at 1 site in United States.
Trial summary
Hemiplegia occurs when the function of motor areas in the brain become impaired, predominantly unilaterally, during perinatal development. Children with hemiplegia show impairments in motor control of the affected side of the body. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Cerebral Palsy, Hemiplegia
- What is being tested?
- tDCS plus robotic training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2017to 1 Jun 2023
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6-17
- Participant and caregiver willing and able to provide informed consen/assent
- Diagnosis of hemiplegia
- Joint mobility: wrist extension, 20º, metacarpophalangeal and proximal interphalangeal joints 10º
Who cannot join
- Cognitive deficits that impede understanding of study protocol
- Current medical illness unrelated to CP
- Visual problems (uncorrected by glasses/contact lenses)
- High motor ability in affected arm Pre-intervention screening measures; Motor activity log, score > 2.5 ( > slight-to-moderate)
- Severe spasticity Pre-intervention screening measures; Modified Ashworth test, score > 3 ( > moderate)
- Lack of asymmetry in hand function
Show all 14Show fewer
- Orthopedic surgery in affected arm within 2 years
- Dorsal root rhizotomy
- Botulinum toxin therapy in either upper extremity during last 2 months, or planned during study period
- Currently receiving intrathecal baclofen
- Seizure beyond age 2, use of anti-seizure medication, history of epilepsy (in self or first degree relatives), brain surgery, cranial metal implants, structural brain lesion, devices that may be affected by TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
- True positive response on the Transcranial Magnetic Stimulation Safety Screen
- Current use of medications known to lower the seizure threshold
- Previous episode of neurocardiogenic syncopy
Trial locations and contacts
1 site in 1 country.
About this study
Hemiplegia occurs when the function of motor areas in the brain become impaired, predominantly unilaterally, during perinatal development. Children with hemiplegia show impairments in motor control of the affected side of the body. Impairments in use of the upper extremity are common, and lead to functional disability throughout the lifespan of a person with hemiplegia. Upper extremity impairments can severely affect a person's ability to carry out activities of daily living.
The goal of this study at Blythedale Children's Hospital is to test the efficacy of transcranial direct current stimulation (tDCS) and robotic upper extremity therapy in improving upper extremity function in children with unilateral cerebral palsy. This study will test the hypothesis that physical rehabilitation, provided by repetitive arm movements guided by a robot, will improve upper extremity function in children with hemiplegia, and that this improvement can be enhanced by transcranial direct current stimulation of motor cortex immediately before robotic training.
Read the detailed description
This sham-controlled, double-blind study will be completed at Blythedale Children's Hospital.
Detailed procedures
Robotic Device and Patient Position
The investigators will use existing robots at Blythedale, which are FDA approved robotic devices that move the shoulder-and-elbow, or wrist-and-forearm, or the Typo Amadeo digit training robot.
All robots: The subject will sit in a foam-padded chair facing the robot and a video screen.
Planar (shoulder-elbow) and wrist robots: The arm will be abducted, forearm supported, and hand lightly grasping the robot handle, and velcro straps will lightly hold the forearm and fingers secure. A cursor on the video screen will display the targets and track the movement of the patient's arm.
Amadeo: The arm will be abducted, forearm supported, and digits attached to the robot with magnets. Velcro straps will lightly hold the forearm and fingers secure. A cursor on the video screen will display the targets and track the movement of the patient's fingers.
Robotic Training
Participants will receive a total of 12 sessions comprising 1 hour of interactive robotic training. Participants will have two to four study visits per week. During one visit, the child will receive tDCS + 1 hr training on the shoulder-elbow MIT Manus robot, and on the second visit of the week, the child will receive tDCS + 1 hr training on the wrist MIT Manus robot.
The interactive robot features involve visuomotor tasks, moving the robotic manipulandum according to targets on a computer screen mounted at eye level. A key feature of MIT robots is the low near isotropic inertia and reduced friction in the robot arm so that, when appropriate, it can "get out of the way." The force required to move the robotic arm is minimal, comparable to moving unrestricted, and if a patient cannot move the robot arm, it will guide the limb to provide an adaptive sensorimotor experience.
Transcranial Direct Current Stimulation
A current up to 1.5mA current will be delivered using surface rubber-carbon electrodes (35cm2) with surrounding saline soaked sponges (0.9% NaCl) by a battery driven, constant current stimulator (maximum output 2mA). Participants will receive stimulation for 20 minutes while seated (before robotic motor training), with the anode over the optimal site for first dorsal interosseous (FDI) as identified using TMS, and the cathode on the contralateral supraorbital area. Sham tDCS: comparable set-up to real tDCS, 30 sec real current ramping to current up to 1.5mA at commencement, then after 5 sec a slow decrease but to no current sustained for 20mins.
- Conditions
- Cerebral Palsy, Hemiplegia
- Being tested
- tDCS plus robotic training
- Medical subject headings
- Cerebral Palsy, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS plus robotic trainingOther
Children will first receive 20 min of tDCS (real or sham, see Arms), then will receive 1 hr of upper limb robotic therapy in which the child will use their impaired arm and hand to move a joystick controlling a cursor to a set of targets on a video screen in front of the child.
| Study group | Role | What they receive |
|---|---|---|
| Real tDCS plus robotic training | Experimental | Children will receive 20 min of real tDCS stimulation per session, followed by robotic training for 1 hr. Receives: Other: tDCS plus robotic training |
| Sham tDCS plus robotic training | Sham comparator | Children will receive 20 min of sham tDCS stimulation per session, followed by robotic training for 1 hr. Receives: Other: tDCS plus robotic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Assisting Hand Assessment after intervention
Assessment of how well children incorporate both hands into bimanual task performance, using an assessment tool called the "Assisting Hand Assessment"
Measured: Within one week after the intervention ends
Change in Jebsen-Taylor Test of Hand Function after intervention
Assessment of unimanual movement speed
Measured: Within one week after the intervention ends
Change in Box and blocks test after intervention
Assessment of unimanual function
Measured: Within one week after the intervention ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start12 Jun 2017
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (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.
- 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
- Crossover
- Model description
- Children will be randomized to receive either real or sham tDCS plus robotic training. Children in the sham group will be given the opportunity to repeat the protocol and receive real stimulation after they complete the sham protocol.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blythedale Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Friel, Blythedale Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145532
- Sponsor's protocol ID
- 16-1003KF
- Status last verified
- Jan 2022
- First submitted
- 4 May 2017
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan to share deidentified data in the NIH DASH (Data and Specimen Hub) database, sponsored by the National Institute of Child Health and Development (NICHD). Data will be archived to DASH upon study completion.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct-Current Stimulation (tCDS) and Robotics for Children With Hemiplegia
- ClinicalTrials.gov ID
- NCT03145532
- Acronym / sponsor ID
- 16-1003KF
- Conditions
- Cerebral Palsy, Hemiplegia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Blythedale Children's HospitalUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 9 May 2017 (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.
Hemiplegia occurs when the function of motor areas in the brain become impaired, predominantly unilaterally, during perinatal development. Children with hemiplegia show impairments in motor control of the affected side of the body. Impairments in use of the upper extremity are common, and lead to functional disability throughout the lifespan of a person with hemiplegia. Upper extremity impairments can severely affect a person's ability to carry out activities of daily living.
The goal of this study at Blythedale Children's Hospital is to test the efficacy of transcranial direct current stimulation (tDCS) and robotic upper extremity therapy in improving upper extremity function in children with unilateral cerebral palsy. This study will test the hypothesis that physical rehabilitation, provided by repetitive arm movements guided by a robot, will improve upper extremity function in children with hemiplegia, and that this improvement can be enhanced by transcranial direct current stimulation of motor cortex immediately before robotic training.
Detailed description
This sham-controlled, double-blind study will be completed at Blythedale Children's Hospital.
Detailed procedures
Robotic Device and Patient Position
The investigators will use existing robots at Blythedale, which are FDA approved robotic devices that move the shoulder-and-elbow, or wrist-and-forearm, or the Typo Amadeo digit training robot.
All robots: The subject will sit in a foam-padded chair facing the robot and a video screen.
Planar (shoulder-elbow) and wrist robots: The arm will be abducted, forearm supported, and hand lightly grasping the robot handle, and velcro straps will lightly hold the forearm and fingers secure. A cursor on the video screen will display the targets and track the movement of the patient's arm.
Amadeo: The arm will be abducted, forearm supported, and digits attached to the robot with magnets. Velcro straps will lightly hold the forearm and fingers secure. A cursor on the video screen will display the targets and track the movement of the patient's fingers.
Robotic Training
Participants will receive a total of 12 sessions comprising 1 hour of interactive robotic training. Participants will have two to four study visits per week. During one visit, the child will receive tDCS + 1 hr training on the shoulder-elbow MIT Manus robot, and on the second visit of the week, the child will receive tDCS + 1 hr training on the wrist MIT Manus robot.
The interactive robot features involve visuomotor tasks, moving the robotic manipulandum according to targets on a computer screen mounted at eye level. A key feature of MIT robots is the low near isotropic inertia and reduced friction in the robot arm so that, when appropriate, it can "get out of the way." The force required to move the robotic arm is minimal, comparable to moving unrestricted, and if a patient cannot move the robot arm, it will guide the limb to provide an adaptive sensorimotor experience.
Transcranial Direct Current Stimulation
A current up to 1.5mA current will be delivered using surface rubber-carbon electrodes (35cm2) with surrounding saline soaked sponges (0.9% NaCl) by a battery driven, constant current stimulator (maximum output 2mA). Participants will receive stimulation for 20 minutes while seated (before robotic motor training), with the anode over the optimal site for first dorsal interosseous (FDI) as identified using TMS, and the cathode on the contralateral supraorbital area. Sham tDCS: comparable set-up to real tDCS, 30 sec real current ramping to current up to 1.5mA at commencement, then after 5 sec a slow decrease but to no current sustained for 20mins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Children will be randomized to receive either real or sham tDCS plus robotic training. Children in the sham group will be given the opportunity to repeat the protocol and receive real stimulation after they complete the sham protocol.
| Arm | Type | Receives |
|---|---|---|
| Real tDCS plus robotic training | Experimental | Other: tDCS plus robotic trainingChildren will receive 20 min of real tDCS stimulation per session, followed by robotic training for 1 hr. |
| Sham tDCS plus robotic training | Sham comparator | Other: tDCS plus robotic trainingChildren will receive 20 min of sham tDCS stimulation per session, followed by robotic training for 1 hr. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 6-17
- Participant and caregiver willing and able to provide informed consen/assent
- Diagnosis of hemiplegia
- Joint mobility: wrist extension, 20º, metacarpophalangeal and proximal interphalangeal joints 10º
Key exclusion criteria (14 listed)
- Cognitive deficits that impede understanding of study protocol
- Current medical illness unrelated to CP
- Visual problems (uncorrected by glasses/contact lenses)
- High motor ability in affected arm Pre-intervention screening measures; Motor activity log, score > 2.5 ( > slight-to-moderate)
- Severe spasticity Pre-intervention screening measures; Modified Ashworth test, score > 3 ( > moderate)
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 |
|---|---|---|
| tDCS plus robotic trainingChildren will first receive 20 min of tDCS (real or sham, see Arms), then will receive 1 hr of upper limb robotic therapy in which the child will use their impaired arm and hand to move a joystick controlling a cursor to a set of targets on a video screen in front of the child. | Other | Real tDCS plus robotic training, Sham tDCS plus robotic training |
Primary outcome
Change in Assisting Hand Assessment after intervention
Time frame: Within one week after the intervention ends
Assessment of how well children incorporate both hands into bimanual task performance, using an assessment tool called the "Assisting Hand Assessment"
Change in Jebsen-Taylor Test of Hand Function after intervention
Time frame: Within one week after the intervention ends
Assessment of unimanual movement speed
Change in Box and blocks test after intervention
Time frame: Within one week after the intervention ends
Assessment of unimanual function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Individual participant dataSharing planned: Yes. The investigators plan to share deidentified data in the NIH DASH (Data and Specimen Hub) database, sponsored by the National Institute of Child Health and Development (NICHD). Data will be archived to DASH upon study completion.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS plus robotic training in people with Cerebral Palsy and Hemiplegia, run by Blythedale Children's 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 4 inclusion and 14 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 Jan 2022. 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. 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?
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?
Change in Assisting Hand Assessment after intervention (time frame: Within one week after the intervention ends). The study lists 3 primary outcomes in all. 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 Jan 2022.