Primary DystoniaNCT01191307
Assess Specific Kinds of Children Challenges for Neurologic Devices Study
An observational study of Primary Dystonia and Epilepsy, run by Carlos Pena, PhD, MS.
Trial summary
The ASK CHILDREN study is intended to aid in future development of various neurologic devices (i.e. neuroprostheses). The ASK CHILDREN study seeks to use study information obtained to identify more efficient strategies in the evaluation and review of neuroprostheses regulated by the Agency. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Primary Dystonia, Epilepsy, Hydrocephalus
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Dec 2014
- 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 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Primary Dystonia Criteria; Between ages 7 and 15 years of age, Approved medical device for Primary Dystonia, Neurologic device implanted within the past 12 months. Epilepsy Criteria; Between ages 12 and 15 years of age; Neurologic device implantation or surgical (in-hospital) adjustment within the past 12 months; Approved medical device. Pediatric Hydrocephalus Criteria; Between ages 7 and 15 years of age, Approved medical device, Neurologic shunt implantation or surgical (in-hospital) adjustment within the past 12 months. Spinal Cord Injury Criteria; Between ages 14 and 15 years of age, Approved medical device, Neurologic device implanted within the past 12 months. Deaf or Hearing Impaired Criteria; Between ages 7 and 15* years of age, Approved medical device.
Who may be able to join
None listed.
Who cannot join
- Participation in another clinical investigation that could be jeopardized by participation in the current study;
- Children with severe cognitive impairments (such as children with head injuries resulting in severe cognitive impairment) may be excluded because they may not be capable of self-reporting procedures.
- Unable to comply with terms of the study
- Epilepsy Inclusion Criteria
- Between ages 12 and 15 years of age;
- Neurologic device implantation or surgical (in-hospital) adjustment within the past 12 months;
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- NeuroCybernetic Prosthesis (NCP®) System (approved or cleared by FDA for pediatric use; the NCP® System is approved for children in ages 12 years and older).
- Signed assent form document from the child; and
- Signed permission form from the parent/guardian).
- Epilepsy Exclusion Criteria
- Participation in another clinical investigation that could be jeopardized by participation in the current study; and
- Children with severe cognitive impairments (such as children with head injuries resulting in severe cognitive impairment) may be excluded because they may not be capable of self-reporting procedures.6
- Unable to comply with terms of the study
- Pediatric Hydrocephalus Inclusion Criteria
- Between ages 7 and 15 years of age;
- Implanted traditional or adjustable hydrocephalus shunt implant (approved or cleared by FDA for pediatric use).
- Neurologic shunt implantation or surgical (in-hospital) adjustment within the past 12 months;
- Signed assent form document from the child
- Signed permission form from the parent/guardian)
- Pediatric Hydrocephalus Exclusion Criteria
- Participation in another clinical investigation that could be jeopardized by participation in the current study; and
- Children with severe cognitive impairments (such as children with head injuries resulting in severe cognitive impairment) may be excluded because they may not be capable of self-reporting procedures.6
- Unable to comply with terms of the study
- Spinal Cord Injury Inclusion Criteria
- Between ages 14 and 15 years of age;
- Vocare® Bladder System implant (approved or cleared by FDA for pediatric use).
- Neurologic device implanted within the past 12 months;
- Signed assent form document from the child
- Signed permission form from the parent/guardian); and
- Spinal Cord Injury Exclusion Criteria
- Participation in another clinical investigation that could be jeopardized by participation in the current study; and
- Children with severe cognitive impairments (such as children with head injuries resulting in severe cognitive impairment) may be excluded because they may not be capable of self-reporting procedures.
- Unable to comply with terms of the study
- Deaf or Hearing Impaired Inclusion Criteria
- Between ages 7 and 15* years of age;
- Implanted cochlear implant (approved or cleared by FDA for pediatric use) with any device adjustment related to device performance or routine care of their current device within the past 12 months;
- Signed assent form document from the child
- Signed permission form from the parent/guardian); and
- Deaf or Hearing Impaired Exclusion Criteria
- Participation in another clinical investigation that could be jeopardized by participation in the current study; and
- Children with severe cognitive impairments (such as children with head injuries resulting in severe cognitive impairment) may be excluded because they may not be capable of self-reporting procedures.
- Unable to comply with terms of the study
About this study
The ASK CHILDREN study is intended to aid in future development of various neurologic devices (i.e. neuroprostheses). The ASK CHILDREN study seeks to use study information obtained to identify more efficient strategies in the evaluation and review of neuroprostheses regulated by the Agency.
Read the detailed description
The ASK CHILDREN study is intended to aid in future development of various neurologic devices (i.e. neuroprostheses). The ASK CHILDREN study seeks to use study information obtained to identify more efficient strategies in the evaluation and review of neuroprostheses regulated by the Agency. Specific aims of the clinical study include: (1) Collecting qualitative and quantitative self-report clinical data (through interviews) from children undergoing treatment related to human factors, safety, usability, and adverse events in patients ages 7 to 15 years old implanted with a neuroprosthesis targeting the brain or spinal cord (at two 6 month intervals); and (2) Establish a science-based framework of recommendations based upon the data collected in the ASK CHILDREN Study to help develop more efficient strategies in evaluating pediatric neuroprostheses regulated by the Agency.
- Keywords
- Primary dystonia, Epilepsy, Hydrocephalus, Bladder Control, Deaf or Hearing Impaired
- Medical subject headings
- Dystonic Disorders, Epilepsy, Hydrocephalus, Hearing Loss
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 |
|---|---|---|
| Shunt Implant | hydropcephalus cohort | |
| Cochlear Implant | hearing impaired cohort | |
| Spinal Cord Stiumulation | spinal cord injury cohort | |
| Vagus Nerve Stimulation | epilepsy cohort | |
| Deep Brain Stimulation | dystonia cohort |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startMar 2009
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DystoniaStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carlos Pena, PhD, MS
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, Carlos Pena, PhD, MS, Food and Drug Administration (FDA)
- Investigators
- Carlos L Pena, PhD, Principal investigator, Food and Drug Administration (FDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191307
- Sponsor's protocol ID
- 09-006C
- Status last verified
- Oct 2016
- First submitted
- 26 Aug 2010
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data sharing will occur via publication.
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess Specific Kinds of Children Challenges for Neurologic Devices Study
- ClinicalTrials.gov ID
- NCT01191307
- Acronym / sponsor ID
- 09-006C
- Keywords
- Primary dystonia, Epilepsy, Hydrocephalus, Bladder Control, Deaf or Hearing Impaired
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Carlos Pena, PhD, MSUS federal agency
- Study start
- Mar 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Aug 2010 (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 ASK CHILDREN study is intended to aid in future development of various neurologic devices (i.e. neuroprostheses). The ASK CHILDREN study seeks to use study information obtained to identify more efficient strategies in the evaluation and review of neuroprostheses regulated by the Agency.
Detailed description
The ASK CHILDREN study is intended to aid in future development of various neurologic devices (i.e. neuroprostheses). The ASK CHILDREN study seeks to use study information obtained to identify more efficient strategies in the evaluation and review of neuroprostheses regulated by the Agency. Specific aims of the clinical study include: (1) Collecting qualitative and quantitative self-report clinical data (through interviews) from children undergoing treatment related to human factors, safety, usability, and adverse events in patients ages 7 to 15 years old implanted with a neuroprosthesis targeting the brain or spinal cord (at two 6 month intervals); and (2) Establish a science-based framework of recommendations based upon the data collected in the ASK CHILDREN Study to help develop more efficient strategies in evaluating pediatric neuroprostheses regulated by the Agency.
Study design
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Shunt Implant | – | –hydropcephalus cohort |
| Cochlear Implant | – | –hearing impaired cohort |
| Spinal Cord Stiumulation | – | –spinal cord injury cohort |
| Vagus Nerve Stimulation | – | –epilepsy cohort |
| Deep Brain Stimulation | – | –dystonia cohort |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Primary Dystonia Criteria; Between ages 7 and 15 years of age, Approved medical device for Primary Dystonia, Neurologic device implanted within the past 12 months. Epilepsy Criteria; Between ages 12 and 15 years of age; Neurologic device implantation or surgical (in-hospital) adjustment within the past 12 months; Approved medical device. Pediatric Hydrocephalus Criteria; Between ages 7 and 15 years of age, Approved medical device, Neurologic shunt implantation or surgical (in-hospital) adjustment within the past 12 months. Spinal Cord Injury Criteria; Between ages 14 and 15 years of age, Approved medical device, Neurologic device implanted within the past 12 months. Deaf or Hearing Impaired Criteria; Between ages 7 and 15* years of age, Approved medical device.
Key inclusion criteria (0 listed)
Key exclusion criteria (42 listed)
- Participation in another clinical investigation that could be jeopardized by participation in the current study;
- Children with severe cognitive impairments (such as children with head injuries resulting in severe cognitive impairment) may be excluded because they may not be capable of self-reporting procedures.
- Unable to comply with terms of the study
- Epilepsy Inclusion Criteria
- Between ages 12 and 15 years of age;
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
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Individual participant dataSharing planned: No. Data sharing will occur via publication.
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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.
Carlos L Pena, PhD principal investigator
Food and Drug Administration (FDA)
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Dystonia and Epilepsy, run by Carlos Pena, PhD, MS.
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 0 inclusion and 42 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: stopped early, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Slow enrollment). 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.
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 25 Oct 2016.