Deep Brain Stimulation (DBS) for Early Stage Parkinson's Disease (PD)

Parkinson's Disease Clinical Trial

Official title:

Safety and Tolerability of Neurostimulation in Early Stage Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00282152
• Other study ID #: 040797
• Secondary ID: 1363G050016
• Status: Completed
• Phase: N/A
• First received: January 23, 2006
• Last updated: February 21, 2017
• Start date: March 2006
• Est. completion date: October 2015

Study information

• Verified date: February 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

B-STN DBS is one of the most effective surgical treatments for PD patients suffering from levodopa-induced motor complications. The relatively low incidence of permanent adverse effects and the potential for neuroprotection and alteration of the natural course of PD suggest a highly favorable benefit-to-risk ratio of this procedure. Since neuroprotection is best applied early in the disease course when there are more surviving neurons, we believe that further investigation of this procedure is warranted. The proposed pilot study will provide the necessary data to substantiate the safety and tolerability of the procedure as well as provide data for the design of a full-scale, multicenter trial to investigate the hypothesis that B-STN DBS is a safe and effective treatment to slow the progression of PD.

Description:

This pilot trial is designed specifically to collect the preliminary safety and tolerability data necessary to conduct a future phase III clinical trial to investigate the hypothesis that deep brain stimulation of the subthalamic nucleus in subjects with early Parkinson's will slow the progression of the disease.

The study design is a prospective, randomized, blinded, single-center trial comparing the safety and tolerability of B-STN DBS + ODT vs. ODT alone (control, standard of care) in 30 subjects (15 per group) with early PD (Hoehn and Yahr stage II when off medication).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2015
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients must have a clinical diagnosis of probable idiopathic PD.

• Demonstrated response to dopaminergic therapy, defined as demonstrating at least 30% improvement in parkinsonian motor signs, based upon the UPDRS motor examination subscore, following the administration of their DA drug(s) during the screening neurological examination.

• Hoehn and Yahr (H&Y) stage II when OFF medication.

• No contraindications to surgery.

• Age between 50 and 75 years old.

• Available for follow-up for four years.

• Informed Consent: The subject understands the risks, benefits, and alternatives to the study procedures and participation in the study.

• MRI within normal range for age.

• Levodopa or dopamine agonist therapy for greater than six months but less than or equal to four years.

Exclusion Criteria:

• Evidence of an alternative diagnosis or secondary parkinsonism, as suggested by features unusual early in the clinical course: Prominent postural instability, freezing phenomena, or hallucinations unrelated to medications in the first 3 years after symptom onset; dementia preceding motor symptoms; supranuclear gaze palsy (other than restriction of upward gaze) or slowing of vertical saccades in the first year; severe, symptomatic dysautonomia unrelated to medications; documentation of a condition known to produce parkinsonism and plausibly connected to the subject's symptoms (such as suitably located focal brain lesions or neuroleptic use within the past 6 months)

• Uncontrolled medical condition or clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension).

• Evidence of dementia

• Major psychiatric disorder

• Previous brain operation or injury.

• Active participation in another clinical trial for the treatment of PD.

• Patients who have demand cardiac pacemakers or implantable cardioverter defibrillators (ICD's).

• Patients who have medical conditions that require repeat MRI scans or diathermy treatments.

• Evidence of existing dyskinesias or motor fluctuations.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• B-STN DBS
Deep brain stimulation (DBS) of both the right and left sub-thalamic nucleus (STN) is an FDA approved treatment for advanced PD. DBS is not approved for early stage PD. The STN is a part of the brain that is very small in size and is located in the middle of the right and left sides of the brain. In this disease, this part of the brain becomes overactive and causes the symptoms of PD. It is thought that using DBS in this area of the brain lessens symptoms and allows patients to take less drug to control the disease. Dosage and frequency are not applicable to the DBS. Once the DBS is placed, unless deemed necessary, it will not be removed.

Drug:
• Optimal drug therapy
The drugs used on this study are not investigational. They are drugs for Parkinson's disease that are standard of care. The drug form, dosage, frequency and duration will vary. Examples of drugs used include carbidopa/levodopa, pramipexole, ropinirole, and selegiline.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Time to reach a 4 point increase (worsening) in UPDRS Motor score		Two years