Trial Outcomes & Findings for Chronic Effects of DBS in Parkinson's Disease and Dystonia (NCT NCT01934296)

NCT ID: NCT01934296

Last Updated: 2023-04-24

Results Overview

To report number of PD patients with reliable cortical and subcortical brain signal recorded using Activa PC+S.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2023-04-24

Participant Flow

Participant milestones

Measure	Chronic Brain Recording This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments. Activa PC+S: Surgical implantation of Activa PC+S as one component of a therapeutic DBS system implantation
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chronic Effects of DBS in Parkinson's Disease and Dystonia

Baseline characteristics by cohort

Measure	Chronic Brain Recording n=9 Participants This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments. Activa PC+S: Surgical implantation of Activa PC+S as one component of a therapeutic DBS system implantation
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	57.44 years STANDARD_DEVIATION 9.32 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: 5 patients with Parkinson's disease

To report number of PD patients with reliable cortical and subcortical brain signal recorded using Activa PC+S.

Outcome measures

Measure

Chronic Brain Recording n=5 Participants This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments. Activa PC+S: Surgical implantation of Activa PC+S as one component of a therapeutic DBS system implantation

Number of Patients With Parkinson's Disease With Reliable Cortical and Sub-cortical Brain Signals

5 Participants

Adverse Events

Chronic Brain Recording

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Chronic Brain Recording n=9 participants at risk This is a one-arm, single-center study of the neurophysiology of human movement disorders with two goals: 1) Assess the feasibility of chronic brain recording using a novel fully implantable pulse generator (Medtronic Activa PC+S), which has the capability of sensing and storing local field potentials (LFPs) recorded from implanted electrodes, in addition to providing therapeutic deep brain stimulation (DBS). 2) Study acute and chronic effects of therapeutic DBS on cortical LFPs. 3) Study feasibility of the use of brain signals as feedback either directly to the patient or for DBS stimulation adjustments. Activa PC+S: Surgical implantation of Activa PC+S as one component of a therapeutic DBS system implantation
Surgical and medical procedures Cerebrospinal Fluid (CSF) collected under scalp	11.1% 1/9 • Number of events 1 • 2 years for each patient
Surgical and medical procedures Fatigue after surgery	11.1% 1/9 • Number of events 1 • 2 years for each patient

Additional Information

Dr. Sarah Wang, Director of Clinical Research

University of California San Francisco

Phone: 416-353-7885

Email: Sarah.Wang@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place