DystoniaPhase 2/3NCT00004421
Deep Brain Stimulation in Treating Patients With Dystonia
A Phase 2/3 study testing implanted pulse generator in people with Dystonia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
RATIONALE: Dystonia is a disorder in which the muscles that control voluntary movements are persistently or intermittently contracted (not relaxed). Deep brain stimulation is provided by a small, battery operated implant placed under the skin of the chest that delivers low voltage electrical pulses through a wire… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dystonia
- What is being tested?
- implanted pulse generator
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1997to Sep 2000
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Idiopathic or secondary cervical, segmental, or generalized dystonia not adequately controlled with traditional pharmacotherapy and/or botulinum toxin --Prior/Concurrent Therapy-- All medical therapy must be stable within the past month Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No prior destructive neurosurgical procedure Other: At least 3 months since prior botulinum toxin injections --Patient Characteristics-- Age: 18 to 75 Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No demand cardiac pacemaker Other: No history of substance abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Medical Center, NY
New York, New York, 10029
About this study
Official title: Phase II/III Study of Deep Brain Stimulation in Patients With Dystonia
RATIONALE: Dystonia is a disorder in which the muscles that control voluntary movements are persistently or intermittently contracted (not relaxed). Deep brain stimulation is provided by a small, battery operated implant placed under the skin of the chest that delivers low voltage electrical pulses through a wire under the skin that is connected to a specific area of the brain. Deep brain stimulation may help lessen the symptoms of dystonia.
PURPOSE: Phase II/III trial to study the effectiveness of deep brain stimulation in treating patients who have dystonia.
Read the detailed description
PROTOCOL OUTLINE: Patients undergo surgery to implant a brain stimulation system consisting of an implanted pulse generator (IPG) in the chest and a wire lead in the globus pallidum internal. After the lead has been implanted, the brain stimulation system is tested. Patients are examined at 1, 3, 6, 9, and 12 months after surgery. A double blinded evaluation, during which the IPG is either off or on, is carried out at 3 and 6 months.
Patients are followed every 3 months as long as the brain stimulation system remains in place.
Completion date provided represents the completion date of the grant per OOPD records
- Conditions
- Dystonia
- Being tested
- implanted pulse generator
- Keywords
- dystonia, neurologic and psychiatric disorders, rare disease
- Medical subject headings
- Dystonia, Neurologic Manifestations, Mental Disorders, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implanted pulse generatorDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startSep 1997
- Study completionSep 2000
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 DystoniaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Investigators
- Mitchell Francis Brin, Study chair, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004421
- Sponsor's protocol ID
- 199/13315
- Other IDs
- MTS-FDR001452
- Status last verified
- Mar 2000
- First submitted
- 18 Oct 1999
- Last updated
- 25 Mar 2015
- Results posted
- No
Publications
Brin MF, Germano I, Danisi FO, et al.: Deep brain stimulation (DBS) of pallidum in intractable dystonia. Movement Disorders 13(suppl 2): 274, 1998.
Germano IM, Villalobos H, Weisz, et al.: Image-guided computer-assisted technology as adjuvant for placement of deep brain stimulators. Movement Disorders 13(suppl 2): 264, 1998.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II/III Study of Deep Brain Stimulation in Patients With Dystonia
- ClinicalTrials.gov ID
- NCT00004421
- Acronym / sponsor ID
- 199/13315
- Conditions
- Dystonia
- Keywords
- dystonia, neurologic and psychiatric disorders, rare disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Sep 1997
- Study completion
- Sep 2000
- First posted
- 19 Oct 1999 (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.
RATIONALE: Dystonia is a disorder in which the muscles that control voluntary movements are persistently or intermittently contracted (not relaxed). Deep brain stimulation is provided by a small, battery operated implant placed under the skin of the chest that delivers low voltage electrical pulses through a wire under the skin that is connected to a specific area of the brain. Deep brain stimulation may help lessen the symptoms of dystonia.
PURPOSE: Phase II/III trial to study the effectiveness of deep brain stimulation in treating patients who have dystonia.
Detailed description
PROTOCOL OUTLINE: Patients undergo surgery to implant a brain stimulation system consisting of an implanted pulse generator (IPG) in the chest and a wire lead in the globus pallidum internal. After the lead has been implanted, the brain stimulation system is tested. Patients are examined at 1, 3, 6, 9, and 12 months after surgery. A double blinded evaluation, during which the IPG is either off or on, is carried out at 3 and 6 months.
Patients are followed every 3 months as long as the brain stimulation system remains in place.
Completion date provided represents the completion date of the grant per OOPD records
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| implanted pulse generator | Device | – |
Primary outcome
Not reported in the source record.
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 25 Mar 2015.
- BackgroundBrin MF, Germano I, Danisi FO, et al.: Deep brain stimulation (DBS) of pallidum in intractable dystonia. Movement Disorders 13(suppl 2): 274, 1998.
- BackgroundGermano IM, Villalobos H, Weisz, et al.: Image-guided computer-assisted technology as adjuvant for placement of deep brain stimulators. Movement Disorders 13(suppl 2): 264, 1998.
Related trials for Dystonia
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Impact of rTMS on Abnormal Cortical fMRI in Patients With Dystonia
Dystonia Disorder
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Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
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Focused Ultrasound Unilateral Pallidotomy for Medication-Refractory Limb Dystonia
Limb Dystonia, Idiopathic Dystonia
Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
Active, not recruitingPhase 1/2
Deep Brain Stimulation Surgery for Focal Hand Dystonia
Dystonia, Focal Dystonia
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.
Mitchell Francis Brin study chair
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing implanted pulse generator in people with Dystonia, run by Icahn School of Medicine at Mount Sinai 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?
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 25 Mar 2015. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004421, 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 25 Mar 2015.