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Humanitarian Device Exemption (Dystonia IRB)

Primary Purpose

Dystonia

Status

Approved for marketing

Phase

Locations

United States

Study Type

Expanded Access

Intervention

Medtronic Activa Gpi

About this trial

This is an expanded access trial for Dystonia focused on measuring Dystonia, DBS

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Vanderbilt University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00580658

First Posted

December 13, 2007

Last Updated

October 9, 2019

Sponsor

Vanderbilt University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00580658

Brief Title

Humanitarian Device Exemption

Acronym

Dystonia IRB

Official Title

Humanitarian Device Exemption for Medtronic Activa Dystonia Therapy

Study Type

Expanded Access

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Approved for marketing

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dystonia

Keywords

Dystonia, DBS

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Medtronic Activa Gpi

Other Intervention Name(s)

DBS, Gpi, Activa Therapy

Intervention Description

Activa Therapy, Gpi

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter E Konrad, MD, Ph.D.

Organizational Affiliation

Vanderbilt University, Dept. Neurosurgery

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dario Englot, MD PhD

Organizational Affiliation

Vanderbilt University, Dept. Neurosurgery

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Thomas L Davis, MD

Organizational Affiliation

Vanderbilt University, Dept. Neurology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

John Y Fang, MD

Organizational Affiliation

Vanderbilt University, Dept. Neurology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt University

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Humanitarian Device Exemption

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