Trial Outcomes & Findings for Adaptive Closed Loop Neuromodulation and Neural Signatures of Parkinson's Disease (NCT NCT02384421)
NCT ID: NCT02384421
Last Updated: 2022-02-01
Results Overview
Beta Band Power will be recorded continuously during intervention (30 minutes). The PC+S streams off power of the local field potential signal measured from the subthalamic nucleus in a frequency band of interest within the beta band (13-30 Hz). The amplitude of the signal, beta power, was streamed from each subthalamic nucleus (STN) during the calibration period of the experiment when DBS was off (i.e., OFF therapy), when continuous DBS was set at the lower and upper stimulation voltage that were found for determining the stimulation limits of adaptive DBS, and during the 30 minutes of aDBS. We calculated the median observed beta power during aDBS. To compute normalized beta band power, the median value was divided by the observed beta power OFF therapy and during the continuous DBS at the lower and upper voltage. A value less than 1 indicates reduced beta power during aDBS compared to the other conditions.
COMPLETED
NA
22 participants
30 minutes
2022-02-01
Participant Flow
Participant milestones
| Measure |
Activa PC+S Neurostimulator
Participants will be own controls and undergo both Adaptive DBS (Activa PC+S Neurostimulator) and Continuous DBS (Activa PC+S Neurostimulator) deep brain stimulation testing paradigms using Nexus D research tool
PC+S: Primary Cell+Sensing
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|---|---|
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Overall Study
STARTED
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22
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Overall Study
COMPLETED
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22
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adaptive Closed Loop Neuromodulation and Neural Signatures of Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Activa PC+S Neurostimulator
n=22 Participants
Participants will be own controls and undergo both Adaptive DBS and Continuous DBS deep brain stimulation
|
|---|---|
|
Age, Continuous
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58.6 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
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6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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22 Participants
n=5 Participants
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Mean OFF UPDRS-III at Initial Programming
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41.9 UPDRS-III Score
STANDARD_DEVIATION 15.4 • n=5 Participants
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PRIMARY outcome
Timeframe: 30 minutesPopulation: Participants who were assessed for this outcome and with no artifacts in the local field potential signal.
Beta Band Power will be recorded continuously during intervention (30 minutes). The PC+S streams off power of the local field potential signal measured from the subthalamic nucleus in a frequency band of interest within the beta band (13-30 Hz). The amplitude of the signal, beta power, was streamed from each subthalamic nucleus (STN) during the calibration period of the experiment when DBS was off (i.e., OFF therapy), when continuous DBS was set at the lower and upper stimulation voltage that were found for determining the stimulation limits of adaptive DBS, and during the 30 minutes of aDBS. We calculated the median observed beta power during aDBS. To compute normalized beta band power, the median value was divided by the observed beta power OFF therapy and during the continuous DBS at the lower and upper voltage. A value less than 1 indicates reduced beta power during aDBS compared to the other conditions.
Outcome measures
| Measure |
Activa PC+S Neurostimulator
n=20 STNs
Participants will be own controls and undergo both Adaptive DBS and Continuous DBS deep brain stimulation
|
|---|---|
|
Normalized Beta Band Power (13-30 Hz) During aDBS
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0.26 Normalized median beta power
Standard Deviation 0.14
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PRIMARY outcome
Timeframe: 30 minutesPopulation: Participants who were assessed for this outcome (had a clinical UPDRS assessment).
Movement Disorder Society's Unified Parkinson's Disease Rating Scale III (UPDRS III) score will be measured after 30 minutes of intervention and compared to baseline. Scores on the UPDRS III range from 0-132. Higher scores represent a worse outcome. For some participants, a modified UPDRS III was used in which items 3.9, 3.10, 3.11, 3.12, and 3.13 were excluded to only focus on the seated portion of the assessment, or only one hemibody was tested if the aDBS controller was only controlling one subthalamic nucleus.
Outcome measures
| Measure |
Activa PC+S Neurostimulator
n=8 Participants
Participants will be own controls and undergo both Adaptive DBS and Continuous DBS deep brain stimulation
|
|---|---|
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Change in UPDRS III Score
OFF
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28.1 score on a scale
Standard Deviation 17.1
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Change in UPDRS III Score
aDBS
|
12.5 score on a scale
Standard Deviation 10.5
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SECONDARY outcome
Timeframe: 30 minutesPopulation: Participants who were assessed for this outcome and not excluded due to lack of tremor.
Mean tremor power calculated from a triaxial gyroscope using a fast Fourier transform averaged between 4 and 8 Hz. Higher tremor power indicates worse tremor.
Outcome measures
| Measure |
Activa PC+S Neurostimulator
n=10 STNs
Participants will be own controls and undergo both Adaptive DBS and Continuous DBS deep brain stimulation
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|---|---|
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Disease Symptoms (Tremor)
OFF
|
0.040 (rad/s)^2
Standard Deviation 0.11
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|
Disease Symptoms (Tremor)
aDBS
|
0.0072 (rad/s)^2
Standard Deviation 0.018
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SECONDARY outcome
Timeframe: 30 minutesPopulation: Participants who were assessed for this outcome and with no artifacts in the local field potential signal, artifacts in the kinematic data, or excluded since they did not identify as freezers.
Percent time freezing during a stepping-in-place task. Higher percent time freezing represents a worse outcome.
Outcome measures
| Measure |
Activa PC+S Neurostimulator
n=5 Participants
Participants will be own controls and undergo both Adaptive DBS and Continuous DBS deep brain stimulation
|
|---|---|
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Disease Symptoms (Freezing of Gait)
OFF
|
22 percentage of time freezing
Standard Deviation 30
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Disease Symptoms (Freezing of Gait)
aDBS
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0 percentage of time freezing
Standard Deviation 1
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SECONDARY outcome
Timeframe: 30 minutesPopulation: Participants who were assessed for this outcome and with no artifacts in the local field potential signal, substantial tremor in the tested limb, or technical issues during the kinematic recording.
The root mean squared of the angular velocity during a wrist-flexion extension task. Higher root mean squared of angular velocity represents a better outcome.
Outcome measures
| Measure |
Activa PC+S Neurostimulator
n=13 Participants
Participants will be own controls and undergo both Adaptive DBS and Continuous DBS deep brain stimulation
|
|---|---|
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Disease Symptoms (Bradykinesia)
OFF
|
352.58 root mean squared of angular velocity
Standard Deviation 56.46
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|
Disease Symptoms (Bradykinesia)
aDBS
|
457.44 root mean squared of angular velocity
Standard Deviation 58.96
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SECONDARY outcome
Timeframe: 30 minutesPopulation: Participants who were assessed for this outcome and with no artifacts in the local field potential signal.
The median stimulation voltage during the aDBS run was determined for each individual's subthalamic nucleus. The overall group mean of the median stimulation voltages was compared to the group mean of the clinical continuous DBS (cDBS) median voltages.
Outcome measures
| Measure |
Activa PC+S Neurostimulator
n=20 STNs
Participants will be own controls and undergo both Adaptive DBS and Continuous DBS deep brain stimulation
|
|---|---|
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DBS Voltage
Clinical Open Loop (cDBS)
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3.12 median stimulation voltage
Standard Deviation 0.54
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DBS Voltage
aDBS
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2.03 median stimulation voltage
Standard Deviation 0.91
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Adverse Events
Activa PC+S Neurostimulator
Serious adverse events
| Measure |
Activa PC+S Neurostimulator
n=22 participants at risk
Participants will be own controls and undergo both Adaptive DBS and Continuous DBS deep brain stimulation
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|---|---|
|
Infections and infestations
Infection
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4.5%
1/22 • Number of events 1 • Up to six years
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Product Issues
Lead/Connection Break
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4.5%
1/22 • Number of events 1 • Up to six years
|
|
Psychiatric disorders
Suicidality
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4.5%
1/22 • Number of events 1 • Up to six years
|
|
Injury, poisoning and procedural complications
Femur fracture
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4.5%
1/22 • Number of events 1 • Up to six years
|
Other adverse events
| Measure |
Activa PC+S Neurostimulator
n=22 participants at risk
Participants will be own controls and undergo both Adaptive DBS and Continuous DBS deep brain stimulation
|
|---|---|
|
Product Issues
Device Failure
|
4.5%
1/22 • Number of events 1 • Up to six years
|
|
Infections and infestations
Infection
|
4.5%
1/22 • Number of events 1 • Up to six years
|
|
Surgical and medical procedures
Tenderness
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4.5%
1/22 • Number of events 1 • Up to six years
|
|
Product Issues
Sensing Malfunction
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4.5%
1/22 • Number of events 1 • Up to six years
|
|
Product Issues
Device Malfunction
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9.1%
2/22 • Number of events 2 • Up to six years
|
|
Nervous system disorders
Gait Difficulties
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4.5%
1/22 • Number of events 1 • Up to six years
|
|
Nervous system disorders
Speech
|
4.5%
1/22 • Number of events 1 • Up to six years
|
|
Nervous system disorders
Cognitive Difficulties
|
4.5%
1/22 • Number of events 1 • Up to six years
|
|
General disorders
Tingling
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18.2%
4/22 • Number of events 4 • Up to six years
|
|
General disorders
Balance
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22.7%
5/22 • Number of events 6 • Up to six years
|
|
Musculoskeletal and connective tissue disorders
Muscle Soreness
|
9.1%
2/22 • Number of events 2 • Up to six years
|
|
Musculoskeletal and connective tissue disorders
Muscle Contractions
|
45.5%
10/22 • Number of events 18 • Up to six years
|
|
Nervous system disorders
Cognitive Problems
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22.7%
5/22 • Number of events 6 • Up to six years
|
|
Nervous system disorders
Speech Difficulties
|
59.1%
13/22 • Number of events 19 • Up to six years
|
|
Psychiatric disorders
Depression
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13.6%
3/22 • Number of events 4 • Up to six years
|
|
Psychiatric disorders
Suicidal Ideation
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4.5%
1/22 • Number of events 1 • Up to six years
|
|
Musculoskeletal and connective tissue disorders
Slowness
|
9.1%
2/22 • Number of events 3 • Up to six years
|
|
Musculoskeletal and connective tissue disorders
Stiffness
|
45.5%
10/22 • Number of events 16 • Up to six years
|
|
Musculoskeletal and connective tissue disorders
Walking Difficulty
|
72.7%
16/22 • Number of events 27 • Up to six years
|
|
Psychiatric disorders
Anxiety
|
13.6%
3/22 • Number of events 3 • Up to six years
|
|
General disorders
Pain/Soreness
|
18.2%
4/22 • Number of events 5 • Up to six years
|
|
Gastrointestinal disorders
Diverticulitis
|
4.5%
1/22 • Number of events 1 • Up to six years
|
|
Renal and urinary disorders
Urinary Issues
|
9.1%
2/22 • Number of events 2 • Up to six years
|
|
General disorders
Weight changes
|
22.7%
5/22 • Number of events 7 • Up to six years
|
|
Nervous system disorders
Sleep Difficulties
|
36.4%
8/22 • Number of events 12 • Up to six years
|
|
General disorders
Weakness
|
4.5%
1/22 • Number of events 1 • Up to six years
|
|
General disorders
Fatigue
|
22.7%
5/22 • Number of events 15 • Up to six years
|
|
Gastrointestinal disorders
Hernia
|
4.5%
1/22 • Number of events 1 • Up to six years
|
|
Gastrointestinal disorders
Difficult Swallowing/Salivation
|
27.3%
6/22 • Number of events 7 • Up to six years
|
|
Nervous system disorders
Stroke
|
4.5%
1/22 • Number of events 1 • Up to six years
|
|
Psychiatric disorders
Mood
|
13.6%
3/22 • Number of events 3 • Up to six years
|
|
Nervous system disorders
Dreaming
|
4.5%
1/22 • Number of events 1 • Up to six years
|
|
Infections and infestations
Cough/Throat
|
18.2%
4/22 • Number of events 4 • Up to six years
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • Number of events 2 • Up to six years
|
|
General disorders
Dizziness
|
9.1%
2/22 • Number of events 2 • Up to six years
|
|
Nervous system disorders
Restless Leg
|
9.1%
2/22 • Number of events 2 • Up to six years
|
|
General disorders
Headache/Migraine
|
9.1%
2/22 • Number of events 2 • Up to six years
|
|
Psychiatric disorders
Delerium
|
4.5%
1/22 • Number of events 1 • Up to six years
|
|
Eye disorders
Vision problems
|
18.2%
4/22 • Number of events 4 • Up to six years
|
|
Renal and urinary disorders
Kidney Issues
|
4.5%
1/22 • Number of events 1 • Up to six years
|
|
Cardiac disorders
Blood Pressure
|
4.5%
1/22 • Number of events 1 • Up to six years
|
|
General disorders
Body Temperature
|
13.6%
3/22 • Number of events 4 • Up to six years
|
|
Skin and subcutaneous tissue disorders
Hair Loss
|
4.5%
1/22 • Number of events 1 • Up to six years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place