Congenital HemiparesisNCT02015338
Comparing the Location of the Motor Cortex in Children Using Two Methods
An observational study of Congenital Hemiparesis, run by University of Minnesota at 1 site in United States.
Trial summary
Hypothesis: In typically developing children (TDC), use of conventional EEG landmarks to determine the brain area that controls hand function will not differ from TMS-guided determination of individual motor hotspots. In children with hemiparesis, however, those two locations will diverge. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Hemiparesis
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2015
- Phase
- Observational
- 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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with congenital hemiparesis and typically developing children
Who may be able to join
- Typically Developing Children:
- Ages 8-17
- Children with congenital hemiparesis due to hemispheric stroke:
- Ages 8-17
- Equal of greater than 10 degrees of active motion at the metacarpophalangeal joint
- No evidence of seizure activity within the last 2 years.
Who cannot join
- Typically Developing Children:
- neurologic disorders
- indwelling metal
- pregnancy
- history of seizures
- Children with hemiparesis:
Show all 14Show fewer
- Metabolic disorders
- Neoplasm
- Epilepsy
- Disorders of cellular migration and proliferation
- Expressive aphasia
- Pregnancy
- Indwelling metal
- Botulinum toxin or phenol intramuscular block within the one-month preceding TMS application.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Comparing the Location of the Motor Cortex in Children Using Two Methods: EEG and TMS
Hypothesis: In typically developing children (TDC), use of conventional EEG landmarks to determine the brain area that controls hand function will not differ from TMS-guided determination of individual motor hotspots. In children with hemiparesis, however, those two locations will diverge. The prediction is that TMS will best guide Transcranial Direct Current Stimulation (tDCS) interventions
Read the detailed description
Congenital hemiparesis, mainly due to stroke, affects approximately 25% of children with cerebral palsy. Noninvasive brain stimulation has emerged to influence improvements in hand function specifically in children with congenital hemiparesis due to stroke.
The use of one type of noninvasive brain stimulation, Transcranial Direct Current Stimulation (tDCS), in conjunction with rehabilitation training intervention for a child with hemiparesis proposes a synergistic approach to improving hand function. Application of electrodes over certain targeted areas are placed with the intent to stimulate and influence neuronal activity.
Our preliminary evidence suggests that in children with hemiparesis due to stroke, the area for placement is variable as noted by electroencephalogram (EEG) and Transcranial Magnetic Stimulation (TMS) measurement methods, influencing the site location of optimal stimulation for tDCS.
Due to this variation, the optimal site of stimulation warrants investigation for the optimal placement of tDCS.
- Conditions
- Congenital Hemiparesis
- Keywords
- Hemiparesis, Cerebral Palsy, Congenital Stroke, Congenital Infarct
- Medical subject headings
- Paresis, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Typically Developing Children | Children with typical development (e.g. no presence of neurological disorders or diagnoses) | |
| Children with Hemiparesis | Children diagnosed with Hemiparesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the location of the motor cortex by two different means
Determine the location of the motor cortex through two means: 1) The international 10/20 EEG system of measurement and 2) Transcranial Magnetic Stimulation (TMS) testing of cortical excitability in typically developing children and children with hemiparesis.
Measured: 1 year
Secondary outcomes (1)
Measurement of distance in centimeters between the 10/20 EEG C3 or C4 location and the TMS-derived motor hotspot.
Compare the two locations (in each hemisphere) determined by 10/20 EEG system and Transcranial Magnetic Stimulation (TMS) testing and measure in centimeters differences between the two locations.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernadette T Gillick, PhD, MSPT, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015338
- Sponsor's protocol ID
- 1311M45303
- Status last verified
- Jul 2019
- First submitted
- 4 Dec 2013
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Rich TL, Menk JS, Rudser KD, Chen M, Meekins GD, Pena E, Feyma T, Bawroski K, Bush C, Gillick BT. Determining Electrode Placement for Transcranial Direct Current Stimulation: A Comparison of EEG- Versus TMS-Guided Methods. Clin EEG Neurosci. 2017 Nov;48(6):367-375. doi: 10.1177/1550059417709177. Epub 2017 May 22.
PubMed 28530154Rich TL, Menk JS, Rudser KD, Feyma T, Gillick BT. Less-Affected Hand Function in Children With Hemiparetic Unilateral Cerebral Palsy: A Comparison Study With Typically Developing Peers. Neurorehabil Neural Repair. 2017 Oct-Nov;31(10-11):965-976. doi: 10.1177/1545968317739997. Epub 2017 Nov 12.
PubMed 29130382
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Location of the Motor Cortex in Children Using Two Methods: EEG and TMS
- ClinicalTrials.gov ID
- NCT02015338
- Acronym / sponsor ID
- 1311M45303
- Conditions
- Congenital Hemiparesis
- Keywords
- Hemiparesis, Cerebral Palsy, Congenital Stroke, Congenital Infarct
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Dec 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.
Hypothesis: In typically developing children (TDC), use of conventional EEG landmarks to determine the brain area that controls hand function will not differ from TMS-guided determination of individual motor hotspots. In children with hemiparesis, however, those two locations will diverge. The prediction is that TMS will best guide Transcranial Direct Current Stimulation (tDCS) interventions
Detailed description
Congenital hemiparesis, mainly due to stroke, affects approximately 25% of children with cerebral palsy. Noninvasive brain stimulation has emerged to influence improvements in hand function specifically in children with congenital hemiparesis due to stroke.
The use of one type of noninvasive brain stimulation, Transcranial Direct Current Stimulation (tDCS), in conjunction with rehabilitation training intervention for a child with hemiparesis proposes a synergistic approach to improving hand function. Application of electrodes over certain targeted areas are placed with the intent to stimulate and influence neuronal activity.
Our preliminary evidence suggests that in children with hemiparesis due to stroke, the area for placement is variable as noted by electroencephalogram (EEG) and Transcranial Magnetic Stimulation (TMS) measurement methods, influencing the site location of optimal stimulation for tDCS.
Due to this variation, the optimal site of stimulation warrants investigation for the optimal placement of tDCS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Typically Developing Children | – | –Children with typical development (e.g. no presence of neurological disorders or diagnoses) |
| Children with Hemiparesis | – | –Children diagnosed with Hemiparesis |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with congenital hemiparesis and typically developing children
Key inclusion criteria (6 listed)
- Ages 8-17
- Ages 8-17
- Equal of greater than 10 degrees of active motion at the metacarpophalangeal joint
- No evidence of seizure activity within the last 2 years.
Key exclusion criteria (14 listed)
- neurologic disorders
- indwelling metal
- pregnancy
- history of seizures
- Metabolic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the location of the motor cortex by two different means
Time frame: 1 year
Determine the location of the motor cortex through two means: 1) The international 10/20 EEG system of measurement and 2) Transcranial Magnetic Stimulation (TMS) testing of cortical excitability in typically developing children and children with hemiparesis.
1 secondary outcome
Measurement of distance in centimeters between the 10/20 EEG C3 or C4 location and the TMS-derived motor hotspot.
Time frame: 1 year
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 18 Jul 2019.
- Background: PubMed 28530154Rich TL, Menk JS, Rudser KD, Chen M, Meekins GD, Pena E, Feyma T, Bawroski K, Bush C, Gillick BT. Determining Electrode Placement for Transcranial Direct Current Stimulation: A Comparison of EEG- Versus TMS-Guided Methods. Clin EEG Neurosci. 2017 Nov;48(6):367-375. doi: 10.1177/1550059417709177. Epub 2017 May 22.
- Background: PubMed 29130382Rich TL, Menk JS, Rudser KD, Feyma T, Gillick BT. Less-Affected Hand Function in Children With Hemiparetic Unilateral Cerebral Palsy: A Comparison Study With Typically Developing Peers. Neurorehabil Neural Repair. 2017 Oct-Nov;31(10-11):965-976. doi: 10.1177/1545968317739997. Epub 2017 Nov 12.
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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 T Gillick, PhD, MSPT 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?
An observational study of Congenital 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 6 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: finished, as of the sponsor's last update on 18 Jul 2019. 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?
Determine the location of the motor cortex by two different means (time frame: 1 year). 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 NCT02015338, 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 Jul 2019.