DystoniaDystonia IRBNCT00580658
Humanitarian Device Exemption
A study testing Medtronic Activa Gpi in people with Dystonia, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to allow patients to undergo deep brain stimulation (DBS) surgery for the treatment of dystonia. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of the deep brain stimulator device in the treatment of this rare disorder. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Dystonia
- What is being tested?
- Medtronic Activa Gpi
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients whose ages are in the range of 7 and 99 years old
- Patients who are diagnosed with chronic, intractable (drug refractory)primary dystonia, including generalized and or segmental dystonia, hemidystonia, and cervical dystonia (torticollis)as determined by a neurologist or neurosurgeon.
- Patients who have failed appropriate medical therapy as determined by the SMD conference
Who cannot join
- Patients younger than 7 years old
- Patients who are at significant surgical risk as determined by the neurosurgeon and/or anesthesiologist.
- Patients who have not had an adequate trial of medical or non-surgical therapy as determined by the SMD conference.
- Patients not deemed good candidates by the SMD conference group.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Humanitarian Device Exemption for Medtronic Activa Dystonia Therapy
The purpose of this study is to allow patients to undergo deep brain stimulation (DBS) surgery for the treatment of dystonia. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of the deep brain stimulator device in the treatment of this rare disorder. Use of DBS for dystonia is approved for humanitarian use by the FDA in the treatment of chronic, intractable (drug refractory) dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients 7 years or older. Thus, this proposal request authorization by the IRB to allow patients at VUMC to access this HUD therapy.
Read the detailed description
The purpose of this IRB approved study is to allow patients to undergo deep brain stimulation (DBS) surgery for the treatment of dystonia. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of the deep brain stimulator device in the treatment of this rare disorder. Use of DBS for dystonia is approved for humanitarian use by the FDA in the treatment of chronic, intractable (drug refractory) dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients 7 years or older. Thus, this proposal request authorization by the IRB to allow patients at VUMC to access this HUD therapy.
- Conditions
- Dystonia
- Being tested
- Medtronic Activa Gpi
- Keywords
- Dystonia, DBS
- Medical subject headings
- Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Activa GpiDevice
Also called DBS, Gpi, Activa Therapy
Activa Therapy, Gpi
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
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 Vanderbilt University Medical CenterThe 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Konrad, Vanderbilt University
- Investigators
- Peter E Konrad, MD, Ph.D., Principal investigator, Vanderbilt University, Dept. NeurosurgeryDario Englot, MD PhD, Principal investigator, Vanderbilt University, Dept. NeurosurgeryThomas L Davis, MD, Principal investigator, Vanderbilt University, Dept. NeurologyJohn Y Fang, MD, Principal investigator, Vanderbilt University, Dept. Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580658
- Sponsor's protocol ID
- 060155
- Acronym
- Dystonia IRB
- Status last verified
- Oct 2019
- First submitted
- 13 Dec 2007
- Last updated
- 14 Oct 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humanitarian Device Exemption for Medtronic Activa Dystonia Therapy
- ClinicalTrials.gov ID
- NCT00580658
- Acronym / sponsor ID
- Dystonia IRB / 060155
- Conditions
- Dystonia
- Keywords
- Dystonia, DBS
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- First posted
- 27 Dec 2007 (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 purpose of this study is to allow patients to undergo deep brain stimulation (DBS) surgery for the treatment of dystonia. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of the deep brain stimulator device in the treatment of this rare disorder. Use of DBS for dystonia is approved for humanitarian use by the FDA in the treatment of chronic, intractable (drug refractory) dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients 7 years or older. Thus, this proposal request authorization by the IRB to allow patients at VUMC to access this HUD therapy.
Detailed description
The purpose of this IRB approved study is to allow patients to undergo deep brain stimulation (DBS) surgery for the treatment of dystonia. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of the deep brain stimulator device in the treatment of this rare disorder. Use of DBS for dystonia is approved for humanitarian use by the FDA in the treatment of chronic, intractable (drug refractory) dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients 7 years or older. Thus, this proposal request authorization by the IRB to allow patients at VUMC to access this HUD therapy.
Study design
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients whose ages are in the range of 7 and 99 years old
- Patients who are diagnosed with chronic, intractable (drug refractory)primary dystonia, including generalized and or segmental dystonia, hemidystonia, and cervical dystonia (torticollis)as determined by a neurologist or neurosurgeon.
- Patients who have failed appropriate medical therapy as determined by the SMD conference
Key exclusion criteria (4 listed)
- Patients younger than 7 years old
- Patients who are at significant surgical risk as determined by the neurosurgeon and/or anesthesiologist.
- Patients who have not had an adequate trial of medical or non-surgical therapy as determined by the SMD conference.
- Patients not deemed good candidates by the SMD conference group.
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 |
|---|---|---|
| Medtronic Activa GpiAlso: DBS, Gpi, Activa TherapyActiva Therapy, Gpi | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
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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.
Peter E Konrad, MD, Ph.D. principal investigator
Vanderbilt University, Dept. Neurosurgery
Dario Englot, MD PhD principal investigator
Vanderbilt University, Dept. Neurosurgery
Thomas L Davis, MD principal investigator
Vanderbilt University, Dept. Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Activa Gpi in people with Dystonia, run by Vanderbilt University Medical Center 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 4 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: status not confirmed, as of the sponsor's last update on 14 Oct 2019. 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?
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 14 Oct 2019.