Humanitarian Device Exemption | NCT00580658

Studies
Humanitarian Device Exemption

NCT00580658

Sponsor

Vanderbilt University Medical Center

Status

Approved for marketing

Last Update Posted

Oct 14, 2019Actual

Enrollment

Not provided

Phase

Not provided

Conditions

Dystonia

Interventions

Medtronic Activa Gpi

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Approved for marketing

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 13, 2007

First Submission Date that Met QC Criteria

Dec 22, 2007

First Posted Date

Dec 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2019

Last Update Posted Date

Oct 14, 2019Actual

Description Module

Brief 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. 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.

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Medtronic Activa Gpi	Device	Activa Therapy, Gpi		DBS Gpi Activa Therapy

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter E Konrad, MD, Ph.D.	Vanderbilt University, Dept. Neurosurgery	Principal Investigator
Dario Englot, MD PhD	Vanderbilt University, Dept. Neurosurgery	Principal Investigator
Thomas L Davis, MD	Vanderbilt University, Dept. Neurology	Principal Investigator
John Y Fang, MD	Vanderbilt University, Dept. Neurology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University		Nashville	Tennessee	37232	United States

Condition Browse Module

MeSH Terms

ID	Term
D004421	Dystonia

Ancestor Terms

ID	Term
D020820	Dyskinesias
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided