HemiparesisEarly Phase 1tDCSNCT01636661
Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis
A Early Phase 1 study testing tDCS in people with Hemiparesis, run by University of Minnesota at 1 site in United States.
Trial summary
The primary objective of this proposal is to investigate the safety of use of transcranial Direct Current Stimulation (tDCS)in children with hemiparesis. The research question, "Is transcranial Direct Current Stimulation safe for use in children with congenital hemiparesis?" relates to two hypotheses: 1. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Hemiparesis
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Dec 2013
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Congenital Hemiparesis confirmed by most recent MRI or CT radiologic report.
- Hemispheric Stroke or Periventricular Leukomalacia
- Ages 8-17 years old
- ≥ 10 degrees of active motion at the metacarpophalangeal joint
- Adequate receptive language function to follow two-step commands as evidenced by performance on TOKEN test of intelligence
- No evidence of seizure activity within the last 2 years.
- Subject is able to give informed assent and providing a signature, along with the informed consent signature of the legal guardian as evidenced by signature.
Who cannot join
- Metabolic Disorders
- Neoplasm
- Epilepsy
- Disorders of Cellular Migration and Proliferation
- Acquired Traumatic Brain Injury
- Expressive Aphasia
Show all 10Show fewer
- Pregnancy
- Indwelling metal or incompatible medical devices
- Evidence of skin disease or skin abnormalities
- Botulinum toxin or phenol intramuscular block within the one-month preceding tDCS
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The primary objective of this proposal is to investigate the safety of use of transcranial Direct Current Stimulation (tDCS)in children with hemiparesis.
The research question, "Is transcranial Direct Current Stimulation safe for use in children with congenital hemiparesis?" relates to two hypotheses:
- tDCS will not produce a major adverse event, including seizure activity.
- No change in paretic or nonparetic hand function or cognitive status will occur.
Read the detailed description
Completing a pilot safety study is paramount to the future goal of incorporating the tDCS pediatric safety data and combining tDCS and rehabilitation with constraint-induced movement therapy in order to improve motor outcomes beyond what rehabilitation therapies alone can provide and enhance quality of life for these children with hemiparesis.
- Conditions
- Hemiparesis
- Being tested
- tDCS
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called transcranial direct current stimulation
transcranial direct current stimulation- non-invasive brain stimulation
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Direct Current Stimulation | Experimental | Receiving active tDCS Receives: Device: tDCS |
| Sham tDCS | Sham comparator | tDCS equipment set to placebo setting. Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events/Safety Assessment.
Assessment of safety of use of tDCS in children with hemiparesis through vital signs, physician evaluation, subject report of symptoms. Reported are the number of participants who met the following criteria:
- Vital Signs (either resting blood pressure or heart rate)- Any greater than 2SD of change in vital signs from pretest to posttest.
- Physician Evaluation- Child identified as declining in function from pretest to posttest.
- Subject Report of Symptoms- Reports of serious adverse event/symptoms from pretest to posttest.
Detailed adverse events are reported in the adverse events module.
Measured: Baseline, Posttest, Follow-Up Session at One-Week
Secondary outcomes (1)
Hand Function Decline as Measured by Number of Participants
Measured by the Box and Blocks Test and Grip Strength
Measured: Baseline, Posttest, Follow-Up Session at One-Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemiparesisStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Minnesota Medical Foundation
- Responsible party
- Sponsor
- Investigators
- Bernadette Gillick, PhD, MS, PT, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636661
- Sponsor's protocol ID
- 1205M13901
- Acronym
- tDCS
- Status last verified
- Oct 2015
- First submitted
- 11 Jun 2012
- Last updated
- 9 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gillick BT, Feyma T, Menk J, Usset M, Vaith A, Wood TJ, Worthington R, Krach LE. Safety and feasibility of transcranial direct current stimulation in pediatric hemiparesis: randomized controlled preliminary study. Phys Ther. 2015 Mar;95(3):337-49. doi: 10.2522/ptj.20130565. Epub 2014 Nov 20.
PubMed 25413621
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis
- ClinicalTrials.gov ID
- NCT01636661
- Acronym / sponsor ID
- tDCS / 1205M13901
- Conditions
- Hemiparesis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Minnesota Medical Foundation
- Study start
- Jul 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Posted 20 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this proposal is to investigate the safety of use of transcranial Direct Current Stimulation (tDCS)in children with hemiparesis.
The research question, "Is transcranial Direct Current Stimulation safe for use in children with congenital hemiparesis?" relates to two hypotheses:
- tDCS will not produce a major adverse event, including seizure activity.
- No change in paretic or nonparetic hand function or cognitive status will occur.
Detailed description
Completing a pilot safety study is paramount to the future goal of incorporating the tDCS pediatric safety data and combining tDCS and rehabilitation with constraint-induced movement therapy in order to improve motor outcomes beyond what rehabilitation therapies alone can provide and enhance quality of life for these children with hemiparesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulation | Experimental | Device: tDCSReceiving active tDCS |
| Sham tDCS | Sham comparator | Device: tDCStDCS equipment set to placebo setting. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Congenital Hemiparesis confirmed by most recent MRI or CT radiologic report.
- Hemispheric Stroke or Periventricular Leukomalacia
- Ages 8-17 years old
- ≥ 10 degrees of active motion at the metacarpophalangeal joint
- Adequate receptive language function to follow two-step commands as evidenced by performance on TOKEN test of intelligence
Key exclusion criteria (10 listed)
- Metabolic Disorders
- Neoplasm
- Epilepsy
- Disorders of Cellular Migration and Proliferation
- Acquired Traumatic Brain Injury
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 |
|---|---|---|
| tDCSAlso: transcranial direct current stimulationtranscranial direct current stimulation- non-invasive brain stimulation | Device | Sham tDCS, Transcranial Direct Current Stimulation |
Primary outcome
Adverse Events/Safety Assessment.
Time frame: Baseline, Posttest, Follow-Up Session at One-Week
Assessment of safety of use of tDCS in children with hemiparesis through vital signs, physician evaluation, subject report of symptoms. Reported are the number of participants who met the following criteria: 1. Vital Signs (either resting blood pressure or heart rate)- Any greater than 2SD of change in vital signs from pretest to posttest. 2. Physician Evaluation- Child identified as declining in function from pretest to posttest. 3. Subject Report of Symptoms- Reports of serious adverse event/symptoms from pretest to posttest. Detailed adverse events are reported in the adverse events module.
1 secondary outcome
Hand Function Decline as Measured by Number of Participants
Time frame: Baseline, Posttest, Follow-Up Session at One-Week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25413621Gillick BT, Feyma T, Menk J, Usset M, Vaith A, Wood TJ, Worthington R, Krach LE. Safety and feasibility of transcranial direct current stimulation in pediatric hemiparesis: randomized controlled preliminary study. Phys Ther. 2015 Mar;95(3):337-49. doi: 10.2522/ptj.20130565. Epub 2014 Nov 20.
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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.
Bernadette Gillick, PhD, MS, PT principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing tDCS in people with Hemiparesis, run by University of Minnesota 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 7 inclusion and 10 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 9 Nov 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 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adverse Events/Safety Assessment. (time frame: Baseline, Posttest, Follow-Up Session at One-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 NCT01636661, 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 9 Nov 2015.