Status:
UNKNOWN
Simpler and Safer Deep Brain Stimulation for Parkinson's Disease
Lead Sponsor:
North Bristol NHS Trust
Collaborating Sponsors:
Bioinduction
Conditions:
Parkinson's Disease
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The aim is to improve availability and acceptability of deep brain stimulation (DBS) for the treatment of Parkinson by shortening and simplifying the implantation procedure, thereby reducing time in s...
Detailed Description
High-frequency DBS of the STN and STN region is an established treatment for moderate to advanced Parkinson with motor fluctuations, reducing motor symptoms in late stage levodopa responsive patients,...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients who report motor symptoms of Parkinson for at least 4 years;
- Patients eligible for DBS Surgery;
- Receiving stable medical therapy for 30 days or longer before screening assessments - as reported by the patient;
- Males and females aged 21 years or older;
- Be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging systems and completing the motor diary);
- Understands the study requirements and the treatment procedures and is able to provide written informed consent;
- Females of child-bearing potential must have a negative pregnancy test at study entry and report using an effective method of contraception;
- Exclusion criteria:
- Atypical Parkinsonian (Parkinson-plus) syndromes;
- Any prior movement disorder treatments that involved intracranial surgery or device implantation;
- Presence of or planned implant of any other active implanted device;
- Surgical contraindications (such as issues preventing safe anaesthesia);
- Contraindications for MRI scanning (such as presence of metal in the body which means scanning may be harmful);
- Active alcohol or drug abuse;
- Dementia or any neuropsychological condition or finding that would contraindicate DBS surgery. Mattis DRS-2 AEMSS of 6 or less;
- Previous brain surgery likely to interfere with DBS implant;
- Frequent falls when on adequate medication therapy in an "on" state, in the opinion of the PI/delegated clinician;
- A past or current psychiatric disturbance that in the opinion of the PI contraindicates DBS surgery;
- Use of anticoagulant medications that cannot be discontinued during perioperative period;
- Clinically problematic dopamine dysregulation syndrome in the opinion of the PI;
- Significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with expected survival of less than 5 years;
- Participation in another trial concurrently or within 30 days preceding enrolment, that is deemed to interfere with this trial;
- Females who are pregnant, considering becoming pregnant during the study period, or who are breastfeeding.
Exclusion
Key Trial Info
Start Date :
October 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03837314
Start Date
October 28 2020
End Date
January 1 2026
Last Update
October 30 2023
Active Locations (1)
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1
Bristol Brain Centre, Elgar House, Southmead Hospital
Bristol, United Kingdom, BS10 5NB