DystoniaDBS-RNCT06585618
A Multicenter Pediatric Deep Brain Stimulation Registry
An observational study of Dystonia and Epilepsy in Children, run by Boston Children's Hospital at 1 site in United States.
Trial summary
There is limited data on outcomes for children who have undergone deep brain stimulation (DBS) for movement disorders, and individual centers performing this surgery often lack sufficient cases to power research studies adequately. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Dystonia, Epilepsy in Children, Cerebral Palsy
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2024to 30 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population will consist of both female and male patients aged 0 to 18 years who have either received or are scheduled to receive deep brain stimulation (DBS) for any neurological disorder. Eligibility requires that parents or legal guardians are able to provide written consent for prospective enrollment.
Who may be able to join
- Female or male patients between ages of 0-18 years.
- Having received or scheduled to receive DBS for any neurological movement disorder.
- Parents or legal guardians are able to provide written consent for prospective enrollment.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kathryn Yang, MBChB, FRCPC contact
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02215
Darius Ebrahimi-Fakhari, MD, PhD., 617-355-0097, movementdisorders@children.harvard.edu
Kathryn Yang, MD, movementdisorders@children.harvard.edu
About this study
Official title: Multicenter Pediatric Deep Brain Stimulation Registry
There is limited data on outcomes for children who have undergone deep brain stimulation (DBS) for movement disorders, and individual centers performing this surgery often lack sufficient cases to power research studies adequately. This study aims to develop a multicenter pediatric DBS registry that allows multiple sites to share clinical pediatric DBS data. The primary goals are to enable large-scale, well-powered analyses of the safety and efficacy of DBS in the pediatric population and to further explore and refine DBS as a therapeutic option for children with dystonia and other hyperkinetic movement disorders. Given the current scarcity of evidence available to clinicians, this centralized multicenter repository of clinical data is critical for addressing key research questions and improving clinical practice for pediatric DBS.
Read the detailed description
The use of deep brain stimulation (DBS) has expanded to include multiple conditions in children including dystonia, epilepsy, Tourette syndrome and mood disorders. Despite its growing application, DBS remains a low-volume procedure in most pediatric centers, which limits opportunities for large-scale research studies. To overcome this challenge, an international data-sharing platform is essential for advancing knowledge about DBS in pediatric patients, particularly concerning surgical techniques and patient outcomes across various conditions.
This study aims to establish a multicenter pediatric DBS registry. With limited data on pediatric DBS outcomes and a small number of cases at individual centers, there is a need for a comprehensive registry to enable large-scale, well-powered analyses of DBS safety and effectiveness. The primary goals of this study are to:
- Establish and implement a multi-center pediatric DBS registry
- Facilitate large-scale analyses of DBS safety and effectiveness in children
- Refine DBS as a treatment option for dystonia and other hyperkinetic movement disorders in children.
Secondary objectives include:
- Identifying which patients benefit most from DBS
- Determining clinical variables that influence DBS responsiveness
- Identifying optimal implant sites for specific conditions
- Understanding the long-term effects of DBS in children
- Assessing the impact of DBS on the quality of life in pediatric patients
The study will involve both prospective and retrospective data collection from pediatric DBS patients.
- Conditions
- Dystonia, Epilepsy in Children, Cerebral Palsy, Tourette Syndrome, Obsessive-Compulsive Disorder, Neurologic Disorder
- Keywords
- Deep Brain Stimulation, DBS, movement disorder, movement disorders in children, dystonia, chorea, dyskinesia, epilepsy
- Medical subject headings
- Dystonia, Cerebral Palsy, Tourette Syndrome, Obsessive-Compulsive Disorder, Nervous System Diseases, Movement Disorders, Chorea, Dyskinesias
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a Multi-Center Pediatric DBS Registry
This study will define DBS as a therapeutic option for children with dystonia, other hyperkinetic movement disorders, or epilepsy.
Measured: 5 years
Secondary outcomes (1)
Data Collection
Secondary objectives will focus on using the data collected to answer important research questions such as :
- Which patients benefit from DBS?
- Which clinical variables contribute to the responsiveness or nonresponsivness to DBS?
- Which implant sites are preferred?
- What are the long-term effects of DBS in the pediatric population?
- How does DBS affect quality of life in pediatric patients?
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start30 Jul 2024
- Primary completion30 Jul 2029 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (68)Papers the sponsor has linked to this study.
- Other trials for DystoniaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darius Ebrahimi-Fakhari, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585618
- Sponsor's protocol ID
- IRB-P00047069
- Acronym
- DBS-R
- Status last verified
- Mar 2026
- First submitted
- 3 Sep 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Camfield P, Camfield C. Incidence, prevalence and aetiology of seizures and epilepsy in children. Epileptic Disord. 2015 Jun;17(2):117-23. doi: 10.1684/epd.2015.0736.
PubMed 25895502Zesiewicz TA, Sullivan KL, Hauser RA. Levodopa-induced dyskinesia in Parkinson's disease: epidemiology, etiology, and treatment. Curr Neurol Neurosci Rep. 2007 Jul;7(4):302-10. doi: 10.1007/s11910-007-0046-y.
PubMed 17618536Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, Moshe SL, Perucca E, Wiebe S, French J. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia. 2010 Jun;51(6):1069-77. doi: 10.1111/j.1528-1167.2009.02397.x. Epub 2009 Nov 3.
PubMed 19889013Russ SA, Larson K, Halfon N. A national profile of childhood epilepsy and seizure disorder. Pediatrics. 2012 Feb;129(2):256-64. doi: 10.1542/peds.2010-1371. Epub 2012 Jan 23.
PubMed 22271699Sillanpaa M. Long-term outcome of epilepsy. Epileptic Disord. 2000 Jun;2(2):79-88.
PubMed 10954238Vasconcellos E, Wyllie E, Sullivan S, Stanford L, Bulacio J, Kotagal P, Bingaman W. Mental retardation in pediatric candidates for epilepsy surgery: the role of early seizure onset. Epilepsia. 2001 Feb;42(2):268-74. doi: 10.1046/j.1528-1157.2001.12200.x.
PubMed 11240601Wendorff J. [Epilepsy and mental retardation. The school's functioning in children with epilepsy]. Przegl Lek. 2010;67(11):1175-8. Polish.
PubMed 21442972Thompson R, Kerr M, Glynn M, Linehan C. Caring for a family member with intellectual disability and epilepsy: practical, social and emotional perspectives. Seizure. 2014 Nov;23(10):856-63. doi: 10.1016/j.seizure.2014.07.005. Epub 2014 Jul 19.
PubMed 25086700Sanger TD, Chen D, Fehlings DL, Hallett M, Lang AE, Mink JW, Singer HS, Alter K, Ben-Pazi H, Butler EE, Chen R, Collins A, Dayanidhi S, Forssberg H, Fowler E, Gilbert DL, Gorman SL, Gormley ME Jr, Jinnah HA, Kornblau B, Krosschell KJ, Lehman RK, MacKinnon C, Malanga CJ, Mesterman R, Michaels MB, Pearson TS, Rose J, Russman BS, Sternad D, Swoboda KJ, Valero-Cuevas F. Definition and classification of hyperkinetic movements in childhood. Mov Disord. 2010 Aug 15;25(11):1538-49. doi: 10.1002/mds.23088.
PubMed 20589866van Egmond ME, Kuiper A, Eggink H, Sinke RJ, Brouwer OF, Verschuuren-Bemelmans CC, Sival DA, Tijssen MA, de Koning TJ. Dystonia in children and adolescents: a systematic review and a new diagnostic algorithm. J Neurol Neurosurg Psychiatry. 2015 Jul;86(7):774-81. doi: 10.1136/jnnp-2014-309106. Epub 2014 Nov 13.
PubMed 25395479van Egmond ME, Lugtenberg CHA, Brouwer OF, Contarino MF, Fung VSC, Heiner-Fokkema MR, van Hilten JJ, van der Hout AH, Peall KJ, Sinke RJ, Roze E, Verschuuren-Bemelmans CC, Willemsen MA, Wolf NI, Tijssen MA, de Koning TJ. A post hoc study on gene panel analysis for the diagnosis of dystonia. Mov Disord. 2017 Apr;32(4):569-575. doi: 10.1002/mds.26937. Epub 2017 Feb 10.
PubMed 28186668Martin K, Jackson CF, Levy RG, Cooper PN. Ketogenic diet and other dietary treatments for epilepsy. Cochrane Database Syst Rev. 2016 Feb 9;2:CD001903. doi: 10.1002/14651858.CD001903.pub3.
PubMed 26859528Cunha JM, Carlini EA, Pereira AE, Ramos OL, Pimentel C, Gagliardi R, Sanvito WL, Lander N, Mechoulam R. Chronic administration of cannabidiol to healthy volunteers and epileptic patients. Pharmacology. 1980;21(3):175-85. doi: 10.1159/000137430.
PubMed 7413719Mechoulam R, Carlini EA. Toward drugs derived from cannabis. Naturwissenschaften. 1978 Apr;65(4):174-9. doi: 10.1007/BF00450585.
PubMed 351429Devinsky O, Marsh E, Friedman D, Thiele E, Laux L, Sullivan J, Miller I, Flamini R, Wilfong A, Filloux F, Wong M, Tilton N, Bruno P, Bluvstein J, Hedlund J, Kamens R, Maclean J, Nangia S, Singhal NS, Wilson CA, Patel A, Cilio MR. Cannabidiol in patients with treatment-resistant epilepsy: an open-label interventional trial. Lancet Neurol. 2016 Mar;15(3):270-8. doi: 10.1016/S1474-4422(15)00379-8. Epub 2015 Dec 24.
PubMed 26724101
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Pediatric Deep Brain Stimulation Registry
- ClinicalTrials.gov ID
- NCT06585618
- Acronym / sponsor ID
- DBS-R / IRB-P00047069
- Conditions
- Dystonia, Epilepsy in Children, Cerebral Palsy, Tourette Syndrome, Obsessive-Compulsive Disorder, Neurologic Disorder
- Keywords
- Deep Brain Stimulation, DBS, movement disorder, movement disorders in children, dystonia, chorea, dyskinesia, epilepsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Jul 2029 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 5 Sep 2024 (actual)
- 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.
There is limited data on outcomes for children who have undergone deep brain stimulation (DBS) for movement disorders, and individual centers performing this surgery often lack sufficient cases to power research studies adequately. This study aims to develop a multicenter pediatric DBS registry that allows multiple sites to share clinical pediatric DBS data. The primary goals are to enable large-scale, well-powered analyses of the safety and efficacy of DBS in the pediatric population and to further explore and refine DBS as a therapeutic option for children with dystonia and other hyperkinetic movement disorders. Given the current scarcity of evidence available to clinicians, this centralized multicenter repository of clinical data is critical for addressing key research questions and improving clinical practice for pediatric DBS.
Detailed description
The use of deep brain stimulation (DBS) has expanded to include multiple conditions in children including dystonia, epilepsy, Tourette syndrome and mood disorders. Despite its growing application, DBS remains a low-volume procedure in most pediatric centers, which limits opportunities for large-scale research studies. To overcome this challenge, an international data-sharing platform is essential for advancing knowledge about DBS in pediatric patients, particularly concerning surgical techniques and patient outcomes across various conditions.
This study aims to establish a multicenter pediatric DBS registry. With limited data on pediatric DBS outcomes and a small number of cases at individual centers, there is a need for a comprehensive registry to enable large-scale, well-powered analyses of DBS safety and effectiveness. The primary goals of this study are to:
- Establish and implement a multi-center pediatric DBS registry
- Facilitate large-scale analyses of DBS safety and effectiveness in children
- Refine DBS as a treatment option for dystonia and other hyperkinetic movement disorders in children.
Secondary objectives include:
- Identifying which patients benefit most from DBS
- Determining clinical variables that influence DBS responsiveness
- Identifying optimal implant sites for specific conditions
- Understanding the long-term effects of DBS in children
- Assessing the impact of DBS on the quality of life in pediatric patients
The study will involve both prospective and retrospective data collection from pediatric DBS patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population will consist of both female and male patients aged 0 to 18 years who have either received or are scheduled to receive deep brain stimulation (DBS) for any neurological disorder. Eligibility requires that parents or legal guardians are able to provide written consent for prospective enrollment.
Key inclusion criteria (3 listed)
- Female or male patients between ages of 0-18 years.
- Having received or scheduled to receive DBS for any neurological movement disorder.
- Parents or legal guardians are able to provide written consent for prospective enrollment.
Key exclusion criteria (0 listed)
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
Development of a Multi-Center Pediatric DBS Registry
Time frame: 5 years
This study will define DBS as a therapeutic option for children with dystonia, other hyperkinetic movement disorders, or epilepsy.
1 secondary outcome
Data Collection
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 25895502Camfield P, Camfield C. Incidence, prevalence and aetiology of seizures and epilepsy in children. Epileptic Disord. 2015 Jun;17(2):117-23. doi: 10.1684/epd.2015.0736.
- Background: PubMed 17618536Zesiewicz TA, Sullivan KL, Hauser RA. Levodopa-induced dyskinesia in Parkinson's disease: epidemiology, etiology, and treatment. Curr Neurol Neurosci Rep. 2007 Jul;7(4):302-10. doi: 10.1007/s11910-007-0046-y.
- Background: PubMed 19889013Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, Moshe SL, Perucca E, Wiebe S, French J. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia. 2010 Jun;51(6):1069-77. doi: 10.1111/j.1528-1167.2009.02397.x. Epub 2009 Nov 3.
- Background: PubMed 22271699Russ SA, Larson K, Halfon N. A national profile of childhood epilepsy and seizure disorder. Pediatrics. 2012 Feb;129(2):256-64. doi: 10.1542/peds.2010-1371. Epub 2012 Jan 23.
- Background: PubMed 10954238Sillanpaa M. Long-term outcome of epilepsy. Epileptic Disord. 2000 Jun;2(2):79-88.
- Background: PubMed 11240601Vasconcellos E, Wyllie E, Sullivan S, Stanford L, Bulacio J, Kotagal P, Bingaman W. Mental retardation in pediatric candidates for epilepsy surgery: the role of early seizure onset. Epilepsia. 2001 Feb;42(2):268-74. doi: 10.1046/j.1528-1157.2001.12200.x.
- Background: PubMed 21442972Wendorff J. [Epilepsy and mental retardation. The school's functioning in children with epilepsy]. Przegl Lek. 2010;67(11):1175-8. Polish.
- Background: PubMed 25086700Thompson R, Kerr M, Glynn M, Linehan C. Caring for a family member with intellectual disability and epilepsy: practical, social and emotional perspectives. Seizure. 2014 Nov;23(10):856-63. doi: 10.1016/j.seizure.2014.07.005. Epub 2014 Jul 19.
- Background: PubMed 20589866Sanger TD, Chen D, Fehlings DL, Hallett M, Lang AE, Mink JW, Singer HS, Alter K, Ben-Pazi H, Butler EE, Chen R, Collins A, Dayanidhi S, Forssberg H, Fowler E, Gilbert DL, Gorman SL, Gormley ME Jr, Jinnah HA, Kornblau B, Krosschell KJ, Lehman RK, MacKinnon C, Malanga CJ, Mesterman R, Michaels MB, Pearson TS, Rose J, Russman BS, Sternad D, Swoboda KJ, Valero-Cuevas F. Definition and classification of hyperkinetic movements in childhood. Mov Disord. 2010 Aug 15;25(11):1538-49. doi: 10.1002/mds.23088.
- Background: PubMed 25395479van Egmond ME, Kuiper A, Eggink H, Sinke RJ, Brouwer OF, Verschuuren-Bemelmans CC, Sival DA, Tijssen MA, de Koning TJ. Dystonia in children and adolescents: a systematic review and a new diagnostic algorithm. J Neurol Neurosurg Psychiatry. 2015 Jul;86(7):774-81. doi: 10.1136/jnnp-2014-309106. Epub 2014 Nov 13.
- Background: PubMed 28186668van Egmond ME, Lugtenberg CHA, Brouwer OF, Contarino MF, Fung VSC, Heiner-Fokkema MR, van Hilten JJ, van der Hout AH, Peall KJ, Sinke RJ, Roze E, Verschuuren-Bemelmans CC, Willemsen MA, Wolf NI, Tijssen MA, de Koning TJ. A post hoc study on gene panel analysis for the diagnosis of dystonia. Mov Disord. 2017 Apr;32(4):569-575. doi: 10.1002/mds.26937. Epub 2017 Feb 10.
- Background: PubMed 26859528Martin K, Jackson CF, Levy RG, Cooper PN. Ketogenic diet and other dietary treatments for epilepsy. Cochrane Database Syst Rev. 2016 Feb 9;2:CD001903. doi: 10.1002/14651858.CD001903.pub3.
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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.
Kathryn Yang, MBChB, FRCPC contact
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 Dystonia and Epilepsy in Children, run by Boston Children's Hospital 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 0 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Darius Ebrahimi-Fakhari, MD, PhD (617-355-0097, movementdisorders@children.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a Multi-Center Pediatric DBS Registry (time frame: 5 years). 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 NCT06585618, which also lists 68 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 Mar 2026; AzTrials last refreshed its copy on 27 Oct 2026.