Deep brain stimulation of the pedunculopontine nucleus for Parkinson's Disease

Phase 2

Completed

• Conditions: Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Parkinson?s Disease; Disease: Parkinson's disease; Nervous System Diseases; Parkinson's Disease

• Registration Number: ISRCTN16511360
• Lead Sponsor: orth Bristol NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-28
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1. Diagnosis of advanced idiopathic Parkinson's disease poorly controlled on optimum medication with significant functional disability and predominant symptoms of postural instability and gait dysfunction in both the on and off medication states
2. They will have a Unified Parkinson's Disease Rating Scale (UPDRS) motor score of 30 or greater in their practically defined off condition at an initial evaluation. They will each show at least a 30% improvement in the UPDRS motor score from that of the practically defined off condition following a morning levodopa challenge.
3. At two preoperative evaluations the practically defined off UPDRS motor score should differ no more than +/- 15%
4. Subjects will be under the age of 70 years, either sex
5. Appropriate surgical candidate with no medical conditions that would interfere with long-term implantation of device and follow up
6. Patient must give signed informed consent

Exclusion Criteria

1. Known current or past diabetes
2. Evidence of dementia, head trauma or medical conditions that may alter cerebral functioning
3. Past or present history of alcohol or substance abuse
4. Mini-mental state examination (MMSE) scores below 27 or above 30
5. Evidence of past or current serious psychopathology likely to affect the patients ability to benefit from surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified