Pediatric HemiparesisNCT02250092
Brain Stimulation and Hand Training in Children With Hemiparesis
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Pediatric Hemiparesis, run by University of Minnesota at 2 sites in United States.
Trial summary
Hemiparetic cerebral palsy influences motor function in children during development and throughout their lifetime. The deficits one sees are the result both of the congenitally induced brain lesion and the subsequent plasticity that can impair function of the surviving neurons in the damaged brain. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Pediatric Hemiparesis
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Dec 2014to 10 Jul 2017
- Phase
- Interventional
- 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Hemispheric Stroke or Periventricular Leukomalacia confirmed by most recent MRI or CT radiologic report with resultant congenital hemiparesis
- ≥ 10 degrees of active motion at the metacarpophalangeal joint
- 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
- Presence of a motor evoked potential from at least the contralesional hemisphere if not both hemispheres
- Ages 8-21 years
- Able to give informed assent along with the informed consent of the legal guardian
- Children who have had surgeries, which may influence motor function eg- tendon transfer, will be included, yet surgical history will be documented and included in any publication within a participant characteristics table.
Who cannot join
- Metabolic Disorders
- Neoplasm
- Epilepsy
- Disorders of Cellular Migration and Proliferation
- Acquired Traumatic Brain Injury
- Pregnancy
Show all 9Show fewer
- Indwelling metal or incompatible medical devices
- Evidence of skin disease or skin abnormalities
- Botulinum toxin or Phenol block within [six-months] preceding the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Minnesota
Minneapolis, Minnesota, 55455
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, 55101
About this study
Official title: Synergistic Effect of Combined Transcranial Direct Current Stimulation/Constraint Induced Movement Therapy in Children With Hemiparesis
Hemiparetic cerebral palsy influences motor function in children during development and throughout their lifetime. The deficits one sees are the result both of the congenitally induced brain lesion and the subsequent plasticity that can impair function of the surviving neurons in the damaged brain.
Many current treatments have limited influence on children's neurorecovery. Constraint-induced movement therapy (CIMT) involving constraining the unaffected limb to encourage use of the affected limb has shown promise, yet with new technology revealing the potential to directly influence the brain, there is an urgent need to study the synergy of combined techniques.
Read more
Non-invasive brain stimulation (NIBS) as a direct neuromodulatory intervention has the potential to act synergistically with CIMT to influence neurorecovery.
Combining behavioral therapies, constraint-induced movement therapy (CIMT), with a novel form of neuromodulation, transcranial direct current stimulation (tDCS), we investigated the influence of this intervention on improved motor outcomes in children with cerebral palsy. The study hypotheses surround the safety, feasibility and efficacy of combined CIMT and tDCS wherein those children who receive the combined intervention will reveal no major adverse events, yet improved hand function and cortical excitability.
To Note: In addition to the combination of NIBS with CIMT, we also investigated the combination of NIBS with another form of motor intervention, bimanual, or two-handed, training. During bimanual training, children engage both hands in movements. The goal of bimanual training is to teach children how to most effectively use their hands cooperatively. During bimanual training, children play with games and toys that require the use of both hands. Children also practice activities of daily living that require the use of both hands, such as putting hair in a ponytail, tying shoes, and buttoning clothing. N=8 for this pilot study and no randomization. (Burke Medical Research Institute partnered with Columbia University and did a parallel pilot study. N=8 (PIs Friel and Gordon; Protocol BRC449)
Read the detailed description
We use single-pulse transcranial magnetic stimulation (TMS) to measure the location and strength of brain connections that control hand movements.
- Conditions
- Pediatric Hemiparesis
- Being tested
- Transcranial Direct Current Stimulation (tDCS), Placebo Comparator
- Keywords
- Cerebral Palsy, Hemiparesis, Stroke, Non-Invasive Brain Stimulation, Transcranial Direct Current Stimulation, Constraint-Induced Movement Therapy, Diffusion Tensor Imaging, Congenital Hemiparesis, Bimanual Therapy
- Medical subject headings
- Cerebral Palsy, Paresis, Stroke
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 tDCS, Brain Stimulation
10 tDCS/CIMT Sessions
Placebo ComparatorDevice
| Study group | Role | What they receive |
|---|---|---|
| tDCS/CIMT | Active comparator | Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
| tDCS sham/CIMT | Placebo comparator | Placebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. Receives: Device: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Assisting Hand Assessment (AHA)
Participants were videotaped while performing a bimanual age-appropriate activity. Investigators scored this performance using the Assessment of Assisting Hand (AHA) inventory. The AHA consists of 22 items, each scored on a 4-point scale. Raw scores are a sum of the 22 item scores, ranging from 22-88. Computer software logarithmically transforms ordinal raw scores into a final score. Final scores are reported on a logit-based AHA-unit scale and range from 0 to 100, with higher scores indicating greater ability. Outcome is reported as the change from baseline to 2 weeks and change from baseline to 6 months.
Measured: 2 weeks, 6 months
Secondary outcomes (1)
Change in Canadian Occupational Performance Measurement (COPM)
The COPM is clinician-administered semi-structured interview measuring the participant's perception of satisfaction and performance of personally set goals. There are 3 categories (Self-Care, Productivity, and Leisure) each containing 3 subcategories each for a total of 9 items, which are rated on an ordinal scale from 1 (minimum importance) to 10 (maximum importance). Each of the child's goals are given a satisfaction and performance rating. The average of the satisfaction ratings across all goals is reported as the "average satisfaction score", ranging from 1 to 10, with higher scores indicating a better outcome. Outcome is reported as the change from baseline to 2 weeks and change from baseline to 6 months.
Measured: 2 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study start31 Dec 2014
- Primary completion28 Jun 2017
- Study completion10 Jul 2017
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 (2)Papers the sponsor has linked to this study.
- Other trials for Pediatric HemiparesisStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Cerebral Palsy International Research Foundation, Foundation for Physical Therapy, Inc., National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Bernadette T Gillick, PhD, MSPT, PT, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250092
- Sponsor's protocol ID
- 1408M53169
- Status last verified
- Aug 2020
- First submitted
- 18 Sep 2014
- Last updated
- 18 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Gillick B, Menk J, Mueller B, Meekins G, Krach LE, Feyma T, Rudser K. Synergistic effect of combined transcranial direct current stimulation/constraint-induced movement therapy in children and young adults with hemiparesis: study protocol. BMC Pediatr. 2015 Nov 12;15:178. doi: 10.1186/s12887-015-0498-1.
PubMed 26558386Lixandrao MC, Stinear JW, Rich T, Chen CY, Feyma T, Meekins GD, Gillick BT. EMG breakthrough during cortical silent period in congenital hemiparesis: a descriptive case series. Braz J Phys Ther. 2020 Jan-Feb;24(1):20-29. doi: 10.1016/j.bjpt.2018.11.002. Epub 2018 Nov 22.
PubMed 30471965
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Effect of Combined Transcranial Direct Current Stimulation/Constraint Induced Movement Therapy in Children With Hemiparesis
- ClinicalTrials.gov ID
- NCT02250092
- Acronym / sponsor ID
- 1408M53169
- Conditions
- Pediatric Hemiparesis
- Keywords
- Cerebral Palsy, Hemiparesis, Stroke, Non-Invasive Brain Stimulation, Transcranial Direct Current Stimulation, Constraint-Induced Movement Therapy, Diffusion Tensor Imaging, Congenital Hemiparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Cerebral Palsy International Research Foundation, Foundation for Physical Therapy, Inc., National Institutes of Health (NIH)
- Study start
- 31 Dec 2014 (actual)
- Primary completion
- 28 Jun 2017 (actual)
- Study completion
- 10 Jul 2017 (actual)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Posted 18 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hemiparetic cerebral palsy influences motor function in children during development and throughout their lifetime. The deficits one sees are the result both of the congenitally induced brain lesion and the subsequent plasticity that can impair function of the surviving neurons in the damaged brain.
Many current treatments have limited influence on children's neurorecovery. Constraint-induced movement therapy (CIMT) involving constraining the unaffected limb to encourage use of the affected limb has shown promise, yet with new technology revealing the potential to directly influence the brain, there is an urgent need to study the synergy of combined techniques.
Non-invasive brain stimulation (NIBS) as a direct neuromodulatory intervention has the potential to act synergistically with CIMT to influence neurorecovery.
Combining behavioral therapies, constraint-induced movement therapy (CIMT), with a novel form of neuromodulation, transcranial direct current stimulation (tDCS), we investigated the influence of this intervention on improved motor outcomes in children with cerebral palsy. The study hypotheses surround the safety, feasibility and efficacy of combined CIMT and tDCS wherein those children who receive the combined intervention will reveal no major adverse events, yet improved hand function and cortical excitability.
To Note: In addition to the combination of NIBS with CIMT, we also investigated the combination of NIBS with another form of motor intervention, bimanual, or two-handed, training. During bimanual training, children engage both hands in movements. The goal of bimanual training is to teach children how to most effectively use their hands cooperatively. During bimanual training, children play with games and toys that require the use of both hands. Children also practice activities of daily living that require the use of both hands, such as putting hair in a ponytail, tying shoes, and buttoning clothing. N=8 for this pilot study and no randomization. (Burke Medical Research Institute partnered with Columbia University and did a parallel pilot study. N=8 (PIs Friel and Gordon; Protocol BRC449)
Detailed description
We use single-pulse transcranial magnetic stimulation (TMS) to measure the location and strength of brain connections that control hand movements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS/CIMT | Active comparator | Device: Transcranial Direct Current Stimulation (tDCS)Intervention Group will receive 20 minutes of 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. |
| tDCS sham/CIMT | Placebo comparator | Device: Placebo ComparatorPlacebo Group will receive 20 minutes of sham 1.0 mA tDCS to the contralesional hemisphere concurrent with CIMT. |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Hemispheric Stroke or Periventricular Leukomalacia confirmed by most recent MRI or CT radiologic report with resultant congenital hemiparesis
- ≥ 10 degrees of active motion at the metacarpophalangeal joint
- 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
- Presence of a motor evoked potential from at least the contralesional hemisphere if not both hemispheres
Key exclusion criteria (9 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 |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)Also: tDCS, Brain Stimulation10 tDCS/CIMT Sessions | Device | tDCS/CIMT |
| Placebo Comparator | Device | tDCS sham/CIMT |
Primary outcome
Change in Assisting Hand Assessment (AHA)
Time frame: 2 weeks, 6 months
Participants were videotaped while performing a bimanual age-appropriate activity. Investigators scored this performance using the Assessment of Assisting Hand (AHA) inventory. The AHA consists of 22 items, each scored on a 4-point scale. Raw scores are a sum of the 22 item scores, ranging from 22-88. Computer software logarithmically transforms ordinal raw scores into a final score. Final scores are reported on a logit-based AHA-unit scale and range from 0 to 100, with higher scores indicating greater ability. Outcome is reported as the change from baseline to 2 weeks and change from baseline to 6 months.
1 secondary outcome
Change in Canadian Occupational Performance Measurement (COPM)
Time frame: 2 weeks, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26558386Gillick B, Menk J, Mueller B, Meekins G, Krach LE, Feyma T, Rudser K. Synergistic effect of combined transcranial direct current stimulation/constraint-induced movement therapy in children and young adults with hemiparesis: study protocol. BMC Pediatr. 2015 Nov 12;15:178. doi: 10.1186/s12887-015-0498-1.
- Derived from this study: PubMed 30471965Lixandrao MC, Stinear JW, Rich T, Chen CY, Feyma T, Meekins GD, Gillick BT. EMG breakthrough during cortical silent period in congenital hemiparesis: a descriptive case series. Braz J Phys Ther. 2020 Jan-Feb;24(1):20-29. doi: 10.1016/j.bjpt.2018.11.002. Epub 2018 Nov 22.
Related trials for Pediatric Hemiparesis
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Intensive Somatosensory Camp for Manual Function and Participation in Children With Unilateral Cerebral Palsy
Cerebral Palsy
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 T Gillick, PhD, MSPT, PT principal investigator
University of Minnesota
2 sites 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 Pediatric Hemiparesis, run by University of Minnesota at 2 sites 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 8 inclusion and 9 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 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 18 Aug 2020). 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?
Change in Assisting Hand Assessment (AHA) (time frame: 2 weeks, 6 months). 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 NCT02250092, which also lists 2 linked publications.
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 18 Aug 2020.