Parkinson Disease
Conditions
Brief summary
Parkinsonian symptoms, such as freezing of gait (FOG) or hypophonia, play a significant role in reducing quality of life for Parkinson disease (PD) patients, and are poorly responsive or can worsen with deep brain stimulation (DBS). Repeated adjustments of stimulation parameters may be beneficial however, continuous DBS (cDBS) does not adapt to the patients' rapidly fluctuating clinical status and does not take into account reliable and consistent state-trait biomarkers. These biomarkers can be recorded by the electrode itself as local field potentials (LFP). These LFPs can be used to guide stimulation output by means of a 'closed loop' or 'adaptive' DBS (aDBS). This is a pilot, two-phase, double-blinded, cross-over study of chronic Adaptive vs. Continuous STN DBS in patients with PD by using a novel implantable DBS system that can automatically adjust stimulation parameters based on the patient's clinical condition. The study will test the hypothesis that aDBS stimulation will treat motor fluctuations similarly to continuous stimulation but it will be superior to the latter in the treatment of speech, gait impairment and falls.
Interventions
DEVICEAdaptive DBS
aDBS vs cDBS
DEVICEContinuous DBS
aDBS vs cDBS
Sponsors
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* PD treated with bilateral STN DBS using Medtronic lead * Able to provide informed consent and comply with study protocol * Need to replace the implantable pulse generator (IPG) due to battery end of life * Presence of disabling gait and/or balance and/or speech issues, as clinically judged by the PI and the patient * Evidence that these disabling gait and/or balance and/or speech issues are worsened by DBS, i.e. they improve after turning DBS off. * Use of contact 1 and/or 2 on one hemisphere and/or 9 and/or 10 on the other one * Good LFP signal (assessable only after IPG replacement with Percept) in at least one hemisphere
Exclusion criteria
* Previous DBS surgery without Medtronic products * Potential use of any therapeutic stimulation configuration (such as bipolar) during the study which will prevent the use of aDBS * Presence of any other disorders potentially impacting the outcome measures (e.g. orthopaedic issues) * Medically unstable * Severe non-motor problems, such as depression, dementia, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Activities of Daily Living using the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II | Baseline, 5 months after IPG change, 8 months after battery change | Unified Parkinson's Disease Rating Scale (MDS-UPDRS) II: Motor Aspects of Experiences of Daily Living (M-EDL), range 0-52. Lower scores reflect better motor experience. |
| Change in Quality of Life (QoL) using Parkinson's Disease Questionnaire (PDQ39) | Baseline, 5 months after IPG change, 8 months after battery change | Parkinson's Disease Questionnaire (PDQ39): 8 dimensions, 5-point ordinal scoring system, each dimension total score range from 0 to 100. Lower scores reflect better QoL. |
| Change in Gait using the Zeno Walkway by Protokinetics | Baseline, 5 months after IPG change, 8 months after battery change | Gait analysis (off and on medication) using the Zeno Walkway by Protokinetics. |
| Change in Speech Quality using the Praat software (Phonetic Sciences) | Baseline, 5 months after IPG change, 8 months after battery change | Phonetic speech analysis (off and on medication) using the Praat software (Phonetic Sciences, Amsterdam, The Netherlands). Increased phonation reflects better speech quality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Motor Outcomes (adaptive DBS vs continuous DBS arms) using Unified Parkinson's Disease Rating Scale part III (motor examination) | Baseline, 2-5 months after IPG change, 8 months after battery change | Unified Parkinson's Disease Rating Scale motor examination (MDS-UPDRS III) score, range 0-132. Lower scores reflect less motor impairment. |
Countries
Canada
Outcome results
None listed