Movement Disorders in ChildrenNCT05392569
Evoked Potential Recording During DBS Surgery
An observational study of Movement Disorders in Children, run by University of Southern California.
Trial summary
Deep brain stimulation (DBS) has been approved for treatment of dystonia by the FDA under a humanitarian device exemption (HDE) status. DBS has been shown to be very effective in the treatment of a variety of diseases such as Parkinson's disease and essential tremor. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Movement Disorders in Children
- What is being tested?
- Deep Brain Stimulation
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 13 Nov 2013to 2 Nov 2021
- 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 5 years and older
- All sexes
- Child, Adult, Older adult
Study population: Has plans to be implanted with a deep brain stimulator device. Although Medtronic's product information indicate that DBS is for individuals 7 years of age and older some DBS centers such as UCSF have implanted kids younger for off-label use. By including children 5 years of age into our study, we do not exclude children that may receive DBS off-label.
Who may be able to join
- - Subjects 5 years of age and/or older (including adults, ages 18+)
- Has chronic, intractable (drug refractory), generalized dystonia
- DBS surgery must be clinically indicated
Who cannot join
- Contraindication to neurosurgery and or a potentially reversible cause of dystonia that does not include surgery.
About this study
Official title: Intraoperative Evoked Potential Recording for Localization of Deep-Brain Stimulation Electrodes
Deep brain stimulation (DBS) has been approved for treatment of dystonia by the FDA under a humanitarian device exemption (HDE) status. DBS has been shown to be very effective in the treatment of a variety of diseases such as Parkinson's disease and essential tremor. It has been widely used for the treatment of primary and secondary dystonia as well. Surgery involves the placement of the DBS electrode in one or two of the deep nuclei constituting the basal ganglia. A subcutaneous thoracic or abdominal implantable pulse generator is placed and connected to the intracranial electrode. Pulsatile stimulation of the deep brain nuclei has been shown to result in significant improvement in many patients, including restoration of the ability to walk or make voluntary arm movements. A major difficulty with DBS is the accurate placement of the electrode. Adult patients are usually awakened during surgery and micro electrode recordings are used to determine the optimal electrode effectiveness and monitor for side effects. This requires the patient to be awake and cooperate, while on the operating table. When DBS is performed in children, such testing is often not possible because the children are scared or not cooperative when awakened during surgery, the procedure is most often done for Dystonia, which does not respond immediately, and dystonia may cause involuntary movements that could be dangerous in the operating room while the child's brain is exposed. As part of the routine clinical evaluation of target location in the operating room or Neuromodulation Unit, stimulation is performed using the deep brain or depth electrodes, typically at frequencies between 60hz and 185hz. For this research study, stimulation will occur at much lower frequencies, between 9hz and 20hz in order to be able to measure how electrical activity from the deep electrodes spreads to other electrodes or the scalp. As part of the research, peripheral nerves will also be stimulated at the wrist and knee at frequencies of 20hz to 150hz in order to measure the transmission of peripheral nerve stimulation to these areas of the brain. The investigators hope these additional studies will allow discovery for mechanisms that lead to movement disorders including dystonia, and that knowledge of these mechanisms will allow the investigators to develop new, safer, and more effective treatments in the future.
- Conditions
- Movement Disorders in Children
- Being tested
- Deep Brain Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationOther
In addition to standard micro electrode recordings, we propose to measure:
- surface potentials at the scalp (EEG) evoked by stimulation at the DBS electrode site
- micro electrode potentials at the DBS electrode site evoked by stimulation at the median and tibial nerves
- local field potentials at the DBS electrode site evoked by stimulation at the median and tibial nerves
- surface EMG in the first dorsal interosseus and gastrocnemius muscles during stimulation at the DBS electrode site.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Change in Dystonia using the Barry Albright Dystonia Scale
The Barry-Albright Dystonia Scale (BADS) is the most common outcome measure reported in intervention studies for children with dyskinetic cerebral palsy. Dystonia severity is rated on a 5-point (0 - 4), criterion based, ordinal scale for eight body regions (eyes, mouth, neck, trunk, left/right upper extremities and left/right lower extremities. The minimum score value is 0 (least severe) and the maximum score value is 32 (most severe).
Measured: 1,3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start13 Nov 2013
- Primary completion1 Oct 2019
- Study completion2 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Movement Disorders in ChildrenStudies 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terence Sanger, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392569
- Sponsor's protocol ID
- CCI-13-00324
- Status last verified
- May 2022
- First submitted
- 18 May 2022
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hernandez-Martin E, Arguelles E, Zheng Y, Deshpande R, Sanger TD. High-fidelity transmission of high-frequency burst stimuli from peripheral nerve to thalamic nuclei in children with dystonia. Sci Rep. 2021 Apr 19;11(1):8498. doi: 10.1038/s41598-021-88114-w.
PubMed 33875779
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Evoked Potential Recording for Localization of Deep-Brain Stimulation Electrodes
- ClinicalTrials.gov ID
- NCT05392569
- Acronym / sponsor ID
- CCI-13-00324
- Conditions
- Movement Disorders in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 13 Nov 2013 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 26 May 2022 (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.
Deep brain stimulation (DBS) has been approved for treatment of dystonia by the FDA under a humanitarian device exemption (HDE) status. DBS has been shown to be very effective in the treatment of a variety of diseases such as Parkinson's disease and essential tremor. It has been widely used for the treatment of primary and secondary dystonia as well. Surgery involves the placement of the DBS electrode in one or two of the deep nuclei constituting the basal ganglia. A subcutaneous thoracic or abdominal implantable pulse generator is placed and connected to the intracranial electrode. Pulsatile stimulation of the deep brain nuclei has been shown to result in significant improvement in many patients, including restoration of the ability to walk or make voluntary arm movements. A major difficulty with DBS is the accurate placement of the electrode. Adult patients are usually awakened during surgery and micro electrode recordings are used to determine the optimal electrode effectiveness and monitor for side effects. This requires the patient to be awake and cooperate, while on the operating table. When DBS is performed in children, such testing is often not possible because the children are scared or not cooperative when awakened during surgery, the procedure is most often done for Dystonia, which does not respond immediately, and dystonia may cause involuntary movements that could be dangerous in the operating room while the child's brain is exposed. As part of the routine clinical evaluation of target location in the operating room or Neuromodulation Unit, stimulation is performed using the deep brain or depth electrodes, typically at frequencies between 60hz and 185hz. For this research study, stimulation will occur at much lower frequencies, between 9hz and 20hz in order to be able to measure how electrical activity from the deep electrodes spreads to other electrodes or the scalp. As part of the research, peripheral nerves will also be stimulated at the wrist and knee at frequencies of 20hz to 150hz in order to measure the transmission of peripheral nerve stimulation to these areas of the brain. The investigators hope these additional studies will allow discovery for mechanisms that lead to movement disorders including dystonia, and that knowledge of these mechanisms will allow the investigators to develop new, safer, and more effective treatments in the future.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Has plans to be implanted with a deep brain stimulator device. Although Medtronic's product information indicate that DBS is for individuals 7 years of age and older some DBS centers such as UCSF have implanted kids younger for off-label use. By including children 5 years of age into our study, we do not exclude children that may receive DBS off-label.
Key inclusion criteria (3 listed)
- - Subjects 5 years of age and/or older (including adults, ages 18+)
- Has chronic, intractable (drug refractory), generalized dystonia
- DBS surgery must be clinically indicated
Key exclusion criteria (1 listed)
- Contraindication to neurosurgery and or a potentially reversible cause of dystonia that does not include surgery.
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 |
|---|---|---|
| Deep Brain StimulationIn addition to standard micro electrode recordings, we propose to measure: 1. surface potentials at the scalp (EEG) evoked by stimulation at the DBS electrode site 2. micro electrode potentials at the DBS electrode site evoked by stimulation at the median and tibial nerves 3. local field potentials at the DBS electrode site evoked by stimulation at the median and tibial nerves 4. surface EMG in the first dorsal interosseus and gastrocnemius muscles during stimulation at the DBS electrode site. | Other | – |
Primary outcome
Assessment of Change in Dystonia using the Barry Albright Dystonia Scale
Time frame: 1,3,6,12 months
The Barry-Albright Dystonia Scale (BADS) is the most common outcome measure reported in intervention studies for children with dyskinetic cerebral palsy. Dystonia severity is rated on a 5-point (0 - 4), criterion based, ordinal scale for eight body regions (eyes, mouth, neck, trunk, left/right upper extremities and left/right lower extremities. The minimum score value is 0 (least severe) and the maximum score value is 32 (most severe).
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 26 May 2022.
- Background: PubMed 33875779Hernandez-Martin E, Arguelles E, Zheng Y, Deshpande R, Sanger TD. High-fidelity transmission of high-frequency burst stimuli from peripheral nerve to thalamic nuclei in children with dystonia. Sci Rep. 2021 Apr 19;11(1):8498. doi: 10.1038/s41598-021-88114-w.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Movement Disorders in Children, run by University of Southern California.
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 1 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 26 May 2022. 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 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?
Assessment of Change in Dystonia using the Barry Albright Dystonia Scale (time frame: 1,3,6,12 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 NCT05392569, 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 26 May 2022.