Health TrialsbyHealthPanel

Safety and Tolerability of Patterned Stimulation for DBS in the Home Setting

ConditionsParkinson DiseaseDeep Brain Stimulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Florida

About this trial

The primary objective of the proposed pilot study is to assess the safety and tolerability of active patterned Deep Brain Stimulation (pDBS) when administered in a home setting for patients with Parkinson's disease (PD) who have had stable bilateral Subthalamic Nucleus (STN) and Globus Pallidus internus (GPi) DBS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Bilateral STN or GPi DBS with Boston Scientific Vercise Genus DBS System

Diagnosis of Parkinson's disease as confirmed by a movement disorders fellowship trained neurologist

Chronic stable DBS therapy, defined as having DBS therapy for at least 6 months

Disqualifiers

History of previous neurosurgical intervention aside from DBS

Diagnosis of dementia (whether primary or related to Parkinson's disease)

A diagnosis of atypical parkinsonism or secondary parkinsonism at any time after DBS implantation

Trial design

Design model

Crossover

Treatments tested in this trial

  • Biphasic deep brain stimulation

    Device

    Deep brain stimulation using active recharge biphasic waveforms consisting of an equal anodic and cathodic pulse immediately delivered sequentially

  • Conventional deep brain stimulation

    Device

    Conventional deep brain stimulation programming that is currently FDA approved

  • Theta burst deep brain stimulation

    Device

    Deep brain stimulation using a conventional waveform but timed such that in the evening hours (based on device clock) the device will adjust stimulation to bursts of conventional stimulation at 6 per second

  • Multi frequency deep brain stimulation

    Device

    Deep brain stimulation using conventional waveforms but simultaneously delivering high frequency stimulation on the dorsal contacts of the DBS lead and low frequency stimulation on the ventral contacts of the DBS lead

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Biphasic DBS (bDBS)Experimental treatment 2 interventions
Group B: Nocturnal Theta Burst Stimulation (tDBS)Experimental treatment 2 interventions
Group C: Region-Specific Frequency Alternation (fDBS)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Tolerability of patterned DBS

The primary endpoint of this study is the proportion of participants who are able to tolerate patterned DBS (pDBS) for the full two-week intervention period. Tolerability is defined as the ability to remain on the assigned pDBS setting without reverting to an alternative DBS configuration.

Time frame
From enrollment to the end of novel waveform trial period at 2 weeks

Secondary outcomes

1

Change in motor symptom severity

A comparison of the modified MDS-UPDRS between conventional and patterned waveform based on a video assessment

Time frame
From enrollment to the end of study period at 4 weeks
2

Change in quality of life

A comparison of quality of life metrics through the Parkinson's Disease Questionnaire (PDQ-39) between conventional and patterned DBS

Time frame
From enrollment to the end of the study period at 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

Boston Scientific Corporation

Collaborator

Source ClinicalTrials.gov
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