ADAPT-PD
Research type
Research Study
Full title
Adaptive DBS Algorithm for Personalized Therapy in Parkinson’s Disease (ADAPT-PD) Trial
IRAS ID
284253
Contact name
Sandra Jacobs
Contact email
Sponsor organisation
Medtronic
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 8 months, 1 days
Research summary
Research Summary: Deep Brain Stimulation (DBS) Therapy may be used to treat some of the motor complications of Parkinsons Disease that are not adequately controlled with medication. Deep Brain Stimulation Therapy is currently delivered in a continuous fashion (cDBS) where stimulation settings are constant and do not adjust to fluctuations in symptoms typically experienced by Parkinson’s disease patients during medication On and Off states.
The Medtronic Percept PC neurostimulator aDBS is a mode that adapts DBS therapy automatically based on certain brain signals within a range defined by the study doctor. The potential benefits of aDBS being more responsive to an individual patient’s clinical state include a reduction in PD symptoms and side effects and also increasing device battery longevity.
There are two types of aDBS (modes) being tested in this study; Single Threshold and Dual Threshold.
The purpose of this study is to evaluate the safety and effectiveness of adaptive Deep Brain Stimulation (aDBS) for Parkinson’s Disease.Summary of Results:
What Did They Do?
• 85 people with Parkinson’s disease took part in the study.
• The study tested the use of adaptive Deep Brain Stimulation (aDBS). aDBS is a mode that adjusts or adapts DBS therapy automatically based on certain signals in the brain. Participants tried two types of aDBS: “single threshold” (ST-aDBS) and “dual threshold” (DT-aDBS). These terms refer to how the device decides when to adjust the stimulation amplitude.
• Participants kept a diary for 3 days to record how much time each day their symptoms were well controlled, and whether they had any unwanted movements (called “dyskinesias”).
• The study also checked how much electrical energy the device used, which affects how long the battery lasts.What Did They Find?
• Most people (over 79% for ST-aDBS and 91% for DT-aDBS) had comparable time with well-controlled symptoms and no troublesome unwanted movements using aDBS as they did with continuous DBS (cDBS). cDBS means your DBS therapy remains the same until it is manually adjusted.
• The amount of energy used by the device was lower, on average, with single threshold aDBS, which could help the battery last longer.
• Most people (45/52, 87%) who tried aDBS found it comfortable enough to use, and nearly all chose to continue with aDBS after using it for 30 days (44/45, 98%).
• There were no serious safety problems related to the device during the long-term follow-up.
• Some people had mild side effects mainly during the aDBS setup and adjustment phase, like temporary worsening of symptoms, but these usually got better with adjustments to the stimulation parameters and one patient had trouble sleeping. The adjustment visits were successful further supported by the 44/45,98% choosing to continue on aDBS.What Does This Mean?
Adaptive deep brain stimulation (aDBS) is a safe and effective treatment for people with Parkinson’s disease who are already doing well with the standard treatment.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
20/WM/0243
Date of REC Opinion
28 Oct 2020
REC opinion
Further Information Favourable Opinion