NCT00773604

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of deep brain stimulation (DBS) of the subthalamic nucleus (STN)for primary dystonia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 16, 2008

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

February 19, 2019

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

6.7 years

First QC Date

October 7, 2008

Results QC Date

December 18, 2018

Last Update Submit

February 12, 2019

Conditions

Dystonia

Keywords

blepharospasmDeep brain Stimulationcervical dystoniacranial dystoniageneralized dystoniasubthalamic nucleusDBS

Outcome Measures

Primary Outcomes (1)

  • The Toronto Western Spasmodic Rating Scale (TWSTRS) Movement Scores Measured Before DBS Surgery (Baseline) and at 12 Months

    Total TWSTRS score range is 0-88, where higher score indicates worse symptoms. Values are calculated by baseline minus 12 month, where higher difference score of change between baseline and 12 months means better outcome (more improvement)

    Baseline and 12 months

Study Arms (1)

Treatment

OTHER

Deep Brain Stimulation

Device: Medtronic implantable deep brain stimulation (DBS) system

Interventions

Medtronic implantable deep brain stimulation (DBS) systemDEVICE

surgical placement of deep brain stimulation system for treatment of dystonia

Treatment

Eligibility Criteria

Age7 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Refractory primary dystonia diagnosed by a movement disorders neurologist
  • Severe functional impairment despite optimal medical management, including failed botulinum toxin therapy
  • Age 7-80 years (UCSF patients) and 18-80 (VA patients)

You may not qualify if:

  • Patients considered at high risk for elective neurosurgery because of co-morbid conditions
  • Brain MRI showing extensive brain atrophy or small vessel ischemic disease
  • Pregnancy
  • Inability to tolerate awake microelectrode-guided neurosurgery
  • Inability to follow up with post-operative study visits
  • Inability to speak or read English
  • Patients with a score of 4.5 or lower on the BFMDRS movement scale
  • Patients with Secondary dystonia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Francisco Veterans Administration Medical Center

San Francisco, California, 94121, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

  • Ostrem JL, San Luciano M, Dodenhoff KA, Ziman N, Markun LC, Racine CA, de Hemptinne C, Volz MM, Heath SL, Starr PA. Subthalamic nucleus deep brain stimulation in isolated dystonia: A 3-year follow-up study. Neurology. 2017 Jan 3;88(1):25-35. doi: 10.1212/WNL.0000000000003451. Epub 2016 Nov 30.

    PMID: 27903810DERIVED

MeSH Terms

Conditions

DystoniaBlepharospasmTorticollis

Interventions

Deep Brain StimulationDrug Delivery Systems

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsEyelid DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, OperativeDrug Therapy

Results Point of Contact

Title
Jill Ostrem
Organization
University of California, San Francisco
Jill.Ostrem@ucsf.edu
415-353-7885

Study Officials

  • Jill Ostrem, M.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2008

First Posted

October 16, 2008

Study Start

June 1, 2008

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 19, 2019

Results First Posted

February 19, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share

De-identified data may be shared with research collaborators.

Time Frame
De-identified data may be available after results have been published, indefinitely.
Access Criteria
Research collaborations accepted by study investigators

Locations

US(2)