Completed

Phase II/III Study of Deep Brain Stimulation in Patients With Dystonia

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What is being tested

implanted pulse generator

Device
Who is being recruted

Nervous System Diseases+7

+ Pathologic Processes

+ Signs and Symptoms

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2 & 3
Interventional
Study Start: September 1997
See protocol details

Summary

Principal SponsorIcahn School of Medicine at Mount Sinai
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1997

Actual date on which the first participant was enrolled.

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

NCT00004421
Principal SponsorIcahn School of Medicine at Mount Sinai
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Nervous System DiseasesPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsDyskinesiasDisease AttributesMental DisordersDystoniaNeurologic ManifestationsRare Diseases

Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Mount Sinai Medical Center, NY

New York, United StatesOpen Mount Sinai Medical Center, NY in Google Maps
CompletedOne Study Center