Topic: Dementias and Neurodegenerative Diseases Research Network
Conditions
Interventions
Following fully informed consent and surgical implantation of DBS electrodes to both the PPN and subthalamic region bilaterally, patients will enter into an initial 6 week period over which the Subtha
Sponsors
North Bristol NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in frequency of gait freezing, measured for 3 days in each condition and averaged. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life questionnaires (39-item Parkinson's Disease Questionnaire [PDQ-39] and 36-item Short Form Health Survey [SF-36]) 2. The Unified Parkinson's Disease Rating Scale (UPDRS) 3. Change in concomitant antiparkinsonian medications 4. Neuropsychological assessment 5. Parkinson's Disease Non-Motor Symptoms Questionnaire 6. Timed walk, upper and lower limb movements and Purdue Pegboard 7. Tinetti balance and gait assessment tool Measured pre-operatively and after each of the two randomisation settings (which could be at 12 - 18 weeks, or 18 - 30 weeks depending on how long the patient needs to be on each stimulation setting in order to reach a stable clinical state on each of the stimulation settings. | — |
Countries
United Kingdom
Outcome results
None listed