Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
310

Inclusion Criteria

Persistent disabling Parkinson's disease symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy.
Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
Diagnosis of bilateral idiopathic PD (H&Y ≥ 2) with a duration of PD ≥ 5 years.
Persistent disabling Parkinson's disease symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy.
Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
Diagnosis of bilateral idiopathic PD (H&Y ≥ 2) with a duration of PD ≥ 5 years.

Exclusion Criteria

Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.
Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
...
Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.
Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
Any other active implanted devices including neurostimulators and /or drug delivery pumps
Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol
Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure.

Summary

Conditions
Parkinson's Disease
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 22 years and 75 years
Gender
Both males and females

Description

The study is multi-center, prospective, double-blind, randomized (3:1) controlled trial. GUIDE XT may be used for planning of programming as needed.

The study is multi-center, prospective, double-blind, randomized (3:1) controlled trial. GUIDE XT may be used for planning of programming as needed.

Inclusion Criteria

Persistent disabling Parkinson's disease symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy.
Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
Diagnosis of bilateral idiopathic PD (H&Y ≥ 2) with a duration of PD ≥ 5 years.
Persistent disabling Parkinson's disease symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy.
Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
Diagnosis of bilateral idiopathic PD (H&Y ≥ 2) with a duration of PD ≥ 5 years.

Exclusion Criteria

Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.
Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
...
Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.
Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
Any other active implanted devices including neurostimulators and /or drug delivery pumps
Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol
Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure.

Tracking Information

NCT #
NCT01839396
Collaborators
Not Provided
Investigators
  • Principal Investigator: Jerrold Vitek, MD, PhD University of Minnesota, Neurology Department Principal Investigator: Philip Starr, MD, PhD Universiry of California, San Francisco, Surgical Movement Disorders Clinic
  • Jerrold Vitek, MD, PhD University of Minnesota, Neurology Department Principal Investigator: Philip Starr, MD, PhD Universiry of California, San Francisco, Surgical Movement Disorders Clinic
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