DystoniaNCT04568681
Deep Brain Stimulation Effects in Dystonia
An observational study of Dystonia, run by University of Florida at 1 site in United States.
Trial summary
Deep Brain Stimulation (DBS) is an effective therapy for patients with medically refractory primary dystonia. However, DBS programming for dystonia is not standardized and multiple clinic visits are frequently required to adequately control symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dystonia
- What is being tested?
- Deep brain stimulation (DBS)
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2020to 12 Jul 2022
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with dystonia, who have been cleared for DBS surgery or receiving a battery change who will receive the Percept battery.
Who may be able to join
- Patient gives an informed consent.
- Patient is over 18 years of age.
- Having a diagnosis of a primary dystonia confirmed by a trained movement disorders neurologist;
- Having failed or not tolerated conventional medical management, at the discretion of the neurologist managing the patient;
Who cannot join
- Having alternative diagnoses to a primary dystonic syndrome;
- Having comorbid neurodegenerative disorders that may affect mobility or cognition (e.g. comorbid Parkinson's disease);
- Having sequelae of prior brain insult (e.g. prior stroke or brain tumor);
- History of prior resectivebrain surgery (e.g. tumor resection);
- Not being a DBS candidate;
- Selection of alternative targets to conventional GPi;
- Receiving unilateral implants
- Having a higher surgical risk that precludes patient from having standard intraoperative mapping.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep Brain Stimulation Effects in Dystonia: Time Course of Electrophysiological Changes in Treatment
Deep Brain Stimulation (DBS) is an effective therapy for patients with medically refractory primary dystonia. However, DBS programming for dystonia is not standardized and multiple clinic visits are frequently required to adequately control symptoms. We aim to longitudinally record brain signals from patients using a novel neurostimulator that can record brain signals. We will correlate brain signals to clinical severity scores to identify pathological rhythms in the absence of DBS, and we will study the effects of DBS on these signals in order to guide clinical programming. We are going to recruit patients who receive the Medtronic Percept device, which allows for brain signal recordings (this feature is FDA approved). The investigators will be conducting an observational study using this device to collect data that the subjects receive as standard of care.
Read the detailed description
The development of newer technologies has allowed clinicians and researchers to better understand pathophysiological underpinnings of different disorders managed with neuromodulation. There is a paucity of information, however, on dystonia, likely due to its rarity of cases and variability in phenomenology to allow generalization of findings. Possible abnormal brain signals, such as high activity in theta band (defined as rhythms in the 4-12Hz range ), have been proposed by small case series. The development of newer technologies has allowed clinicians and researchers to better understand pathophysiological underpinnings of different disorders managed with neuromodulation. There is a paucity of information, however, on dystonia, likely due to its rarity of cases and variability in phenomenology to allow generalization of findings. Possible abnormal brain signals, such as high activity in theta band (defined as rhythms in the 4-12Hz range ), have been proposed by small case series
- Conditions
- Dystonia
- Being tested
- Deep brain stimulation (DBS)
- Medical subject headings
- Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulation (DBS)Device
Deep brain stimulation is an FDA approved therapy that involves surgical implantation of electrodes in deep brain targets and an implantable pulse generator delivers electrical pulses.
| Study group | Role | What they receive |
|---|---|---|
| Patients with dystonia | Patients with dystonia who have clinically been deemed candidates for DBS surgery. Receives: Device: Deep brain stimulation (DBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Dystonia Rating Scale (UDRS)
A clinical scale fo dystonia severity (0-4, 0:no symptoms, 4:extreme)
Measured: 12 months
Burke-Fahn-Marsden Dystonia Rating Scale
A clinical scale fo dystonia severity (0-4, 0:no symptoms, 4:extreme)
Measured: 12 months
Toronto Western Spasmodic Torticollis Rating Scale
A clinical scale of dystonia severity (0-4, 0:no symptoms, 4:extreme)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start5 Nov 2020
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystoniaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aysegul Gunduz, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568681
- Sponsor's protocol ID
- IRB202002270
- Status last verified
- Jul 2022
- First submitted
- 18 Sep 2020
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation Effects in Dystonia: Time Course of Electrophysiological Changes in Treatment
- ClinicalTrials.gov ID
- NCT04568681
- Acronym / sponsor ID
- IRB202002270
- Conditions
- Dystonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 29 Sep 2020 (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) is an effective therapy for patients with medically refractory primary dystonia. However, DBS programming for dystonia is not standardized and multiple clinic visits are frequently required to adequately control symptoms. We aim to longitudinally record brain signals from patients using a novel neurostimulator that can record brain signals. We will correlate brain signals to clinical severity scores to identify pathological rhythms in the absence of DBS, and we will study the effects of DBS on these signals in order to guide clinical programming. We are going to recruit patients who receive the Medtronic Percept device, which allows for brain signal recordings (this feature is FDA approved). The investigators will be conducting an observational study using this device to collect data that the subjects receive as standard of care.
Detailed description
The development of newer technologies has allowed clinicians and researchers to better understand pathophysiological underpinnings of different disorders managed with neuromodulation. There is a paucity of information, however, on dystonia, likely due to its rarity of cases and variability in phenomenology to allow generalization of findings. Possible abnormal brain signals, such as high activity in theta band (defined as rhythms in the 4-12Hz range ), have been proposed by small case series. The development of newer technologies has allowed clinicians and researchers to better understand pathophysiological underpinnings of different disorders managed with neuromodulation. There is a paucity of information, however, on dystonia, likely due to its rarity of cases and variability in phenomenology to allow generalization of findings. Possible abnormal brain signals, such as high activity in theta band (defined as rhythms in the 4-12Hz range ), have been proposed by small case series
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with dystonia | – | Device: Deep brain stimulation (DBS)Patients with dystonia who have clinically been deemed candidates for DBS surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with dystonia, who have been cleared for DBS surgery or receiving a battery change who will receive the Percept battery.
Key inclusion criteria (4 listed)
- Patient gives an informed consent.
- Patient is over 18 years of age.
- Having a diagnosis of a primary dystonia confirmed by a trained movement disorders neurologist;
- Having failed or not tolerated conventional medical management, at the discretion of the neurologist managing the patient;
Key exclusion criteria (8 listed)
- Having alternative diagnoses to a primary dystonic syndrome;
- Having comorbid neurodegenerative disorders that may affect mobility or cognition (e.g. comorbid Parkinson's disease);
- Having sequelae of prior brain insult (e.g. prior stroke or brain tumor);
- History of prior resectivebrain surgery (e.g. tumor resection);
- Not being a DBS candidate;
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 stimulation (DBS)Deep brain stimulation is an FDA approved therapy that involves surgical implantation of electrodes in deep brain targets and an implantable pulse generator delivers electrical pulses. | Device | Patients with dystonia |
Primary outcome
Unified Dystonia Rating Scale (UDRS)
Time frame: 12 months
A clinical scale fo dystonia severity (0-4, 0:no symptoms, 4:extreme)
Burke-Fahn-Marsden Dystonia Rating Scale
Time frame: 12 months
A clinical scale fo dystonia severity (0-4, 0:no symptoms, 4:extreme)
Toronto Western Spasmodic Torticollis Rating Scale
Time frame: 12 months
A clinical scale of dystonia severity (0-4, 0:no symptoms, 4:extreme)
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 15 Jul 2022.
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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.
Aysegul Gunduz, PhD principal investigator
University of Florida
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, run by University of Florida 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 4 inclusion and 8 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 15 Jul 2022. 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?
Unified Dystonia Rating Scale (UDRS) (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 15 Jul 2022.