Cerebral PalsyNCT03038269
tDCS and Robotic Training in Adults With Cerebral Palsy
A study testing Upper Extremity Robotics, tDCS in people with Cerebral Palsy and Hemiplegia, run by Burke Medical Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to improve arm function in adults with hemiplegic cerebral palsy. Participants will receive transcranial direct current stimulation (or sham) in combination with upper extremity robotic therapy. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Cerebral Palsy, Hemiplegia
- What is being tested?
- Upper Extremity Robotics, tDCS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Dec 2022
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participant willing and able to provide informed consent
- Diagnosis of hemiplegic Cerebral Palsy
- Joint mobility: wrist extention (20 degrees), metacarophalangeal and proximal interphalangeal joints (10 degrees)
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
- Severe spasticity
- 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, deices 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 snycopy
Trial locations and contacts
1 site in 1 country.
United States1 site
Burke Medical Research Institute
White Plains, New York, 10605
About this study
Official title: Transcranial Direct Current Stimulation and Robotic Training in Adults With Cerebral Palsy
The purpose of this study is to improve arm function in adults with hemiplegic cerebral palsy. Participants will receive transcranial direct current stimulation (or sham) in combination with upper extremity robotic therapy.
Read the detailed description
Therapy consists of 20 minutes of non-invasive, low-level brain stimulation (transcranial direct current stimulation, tDCS), followed by one hour of shoulder/wrist robotic training. Participants will be enrolled in therapy 3 times per week for 12 weeks (or 36 sessions). Before and after therapy, participants will receive and assessment of their arm function, as well as an assessment of their brain activity, using electroencephalography (EEG) and transcranial magnetic stimulation (TMS).
- Conditions
- Cerebral Palsy, Hemiplegia
- Being tested
- Upper Extremity Robotics, tDCS
- Keywords
- Robotics, Upper Extremity
- 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.
Upper Extremity Robotics, tDCSBehavioural
Participant will receive 20 minutes of non-invasive brain stimulation followed by one hour of shoulder/wrist robotic training.
| Study group | Role | What they receive |
|---|---|---|
| Sham tDCS | Sham comparator | Participant will receive a placebo-type stimulation followed by upper extremity robotic training. Receives: Behavioral: Upper Extremity Robotics, tDCS |
| Active tDCS | Active comparator | Participant will receive active transcranial direct current stimulation followed by upper extremity robotic training. Receives: Behavioral: Upper Extremity Robotics, tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment of Motor Recovery
Evaluates and measures recovery
Measured: 1 Week
Secondary outcomes (2)
Wolf Motor Function Test
Quantifies upper extremity motor ability through timed and functional tasks
Measured: 1 Week
Box and Blocks Test
Measures unilateral gross motor dexterity.
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study startDec 2013
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burke Medical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Friel, Burke Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038269
- Sponsor's protocol ID
- BRC 467
- Status last verified
- Oct 2022
- First submitted
- 30 Jan 2017
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Friel KM, Lee P, Soles LV, Smorenburg ARP, Kuo HC, Gupta D, Edwards DJ. Combined transcranial direct current stimulation and robotic upper limb therapy improves upper limb function in an adult with cerebral palsy. NeuroRehabilitation. 2017;41(1):41-50. doi: 10.3233/NRE-171455.
PubMed 28505986
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation and Robotic Training in Adults With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03038269
- Acronym / sponsor ID
- BRC 467
- Conditions
- Cerebral Palsy, Hemiplegia
- Keywords
- Robotics, Upper Extremity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Burke Medical Research InstituteUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 31 Jan 2017 (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.
The purpose of this study is to improve arm function in adults with hemiplegic cerebral palsy. Participants will receive transcranial direct current stimulation (or sham) in combination with upper extremity robotic therapy.
Detailed description
Therapy consists of 20 minutes of non-invasive, low-level brain stimulation (transcranial direct current stimulation, tDCS), followed by one hour of shoulder/wrist robotic training. Participants will be enrolled in therapy 3 times per week for 12 weeks (or 36 sessions). Before and after therapy, participants will receive and assessment of their arm function, as well as an assessment of their brain activity, using electroencephalography (EEG) and transcranial magnetic stimulation (TMS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham tDCS | Sham comparator | Behavioral: Upper Extremity Robotics, tDCSParticipant will receive a placebo-type stimulation followed by upper extremity robotic training. |
| Active tDCS | Active comparator | Behavioral: Upper Extremity Robotics, tDCSParticipant will receive active transcranial direct current stimulation followed by upper extremity robotic training. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participant willing and able to provide informed consent
- Diagnosis of hemiplegic Cerebral Palsy
- Joint mobility: wrist extention (20 degrees), metacarophalangeal and proximal interphalangeal joints (10 degrees)
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
- Severe spasticity
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 |
|---|---|---|
| Upper Extremity Robotics, tDCSParticipant will receive 20 minutes of non-invasive brain stimulation followed by one hour of shoulder/wrist robotic training. | Behavioural | Active tDCS, Sham tDCS |
Primary outcome
Fugl-Meyer Assessment of Motor Recovery
Time frame: 1 Week
Evaluates and measures recovery
2 secondary outcomes
Wolf Motor Function Test
Time frame: 1 Week
Box and Blocks Test
Time frame: 1 Week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Results publication: PubMed 28505986Friel KM, Lee P, Soles LV, Smorenburg ARP, Kuo HC, Gupta D, Edwards DJ. Combined transcranial direct current stimulation and robotic upper limb therapy improves upper limb function in an adult with cerebral palsy. NeuroRehabilitation. 2017;41(1):41-50. doi: 10.3233/NRE-171455.
- Individual participant dataSharing planned: No
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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 Upper Extremity Robotics, tDCS in people with Cerebral Palsy and Hemiplegia, run by Burke Medical Research Institute 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 3 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 4 Oct 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?
Fugl-Meyer Assessment of Motor Recovery (time frame: 1 Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03038269, which also lists 1 linked publication.
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 4 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.