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| ID | Type | Description | Link |
|---|---|---|---|
| STUDY00023279 | Other Identifier | University of Minnesota |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The purpose of this research is to examine the possible causes and signs of freezing of gait (FOG) secondary to Parkinson's disease (PD). To achieve this, the study will use the novel (on-label and FDA-approved) local field potential (LFP) measuring capability of the Medtronic Percept™ deep brain stimulation (DBS) system to compare oscillatory activity in people who have Parkinson's disease, with and without freezing of gait (FOG). This will be conducted as three separate experiments, participants may volunteer for one or more experiments:
Experiment 1: The first experiment will compare LFPs during gait initiation with and without a cue, in people with (PD+FOG) and without FOG (PD-FOG).
Experiment 2: The second experiment will compare LFPs during the successful movement transitions vs. freezing-events during a FOG provocation course in people with FOG.
Experiment 3: The third experiment will compare LFPs during rapid alternating movements of the wrist and/or foot, in people with and without FOG
The purpose of this research is to examine the underlying pathophysiology and biomarkers of freezing of gait (FOG) and cueing-evoked improvements. This protocol will use the novel (on-label, FDA-approved) local field potential (LFP)-measuring capability of the Medtronic Percept™ deep brain stimulation (DBS) system to compare oscillatory activity in people who have Parkinson's disease (PD), with and without freezing of gait (FOG). This will be conducted as three separate experiments, participants may volunteer for one or more experiments:
Experiment 1: The first experiment will compare LFPs during gait initiation with and without a cue, in people with (PD+FOG) and without FOG (PD-FOG).
Experiment 2: In the second experiment, the investigators will compare LFPs during the successful movement transitions vs. freezing-events during a FOG provocation course in people with FOG.
Experiment 3: In the third experiment, the investigators will compare LFPs during rapid alternating movements of the wrist and/or foot, in people with and without FOG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson's disease with freezing of gait | Experimental | Participants will have a Medtronic Percept DBS device, diagnosis of idiopathic Parkinson's disease (PD), and freezing of gait (FOG). |
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| Parkinson's disease without freezing of gait | Experimental | Participants will have a Medtronic Percept DBS device and diagnosis of idiopathic Parkinson's disease (PD) without having freezing of gait (FOG). Participants in this arm will not be tested in experiment #2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OFF Parkinson's Medication(s) | Other | Participants will be asked to withhold Parkinson's medications 12 hours prior to their testing visit (if extended-release Parkinson's medications are taken by the participant, they will be asked to withhold these for 24 hours prior to their testing visit). |
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of the anticipatory postural adjustments magnitudes (cm) | Blocks of 10 successful step initiation trials will be performed. Ground reaction forces (Kistler Inc.) will be recorded. | During the intervention |
| Quantification of the anticipatory postural adjustments duration (sec) | Blocks of 10 successful step initiation trials will be performed. Ground reaction forces (Kistler Inc.) will be recorded. | During the intervention |
| Step characteristics of the first two steps, length (cm) | Blocks of 10 successful step initiation trials will be performed. Ground reaction forces (Kistler Inc.) and bipolar surface electromyographic (EMG) signals will be recorded bilaterally from seven muscles (tibialis anterior, soleus, lateral gastrocnemius, rectus femoris, biceps femoris, semimembranosus, gluteus medius) (Delsys, Trigno) at 1000 Hz and synchronized to whole body kinematics (8-camera motion capture system, SIMI Inc. or Qualisys Inc.) collected at 100 or 120 Hz and with 128-channels of EEG data (BioSemi, Amsterdam) collected at 2000 Hz according to the 10:20 international system 35. Additionally, resting-state EEG will be collected, to reference and remove walking artifact 36 . Local field potentials (LFPs) will be recorded on the Medtronic Percept system and synchronized to the other data collection systems by briefly turning the device on and off. | During the intervention |
| Step characteristics of the first two steps, width (cm) | Blocks of 10 successful step initiation trials will be performed. Ground reaction forces (Kistler Inc.) and bipolar surface electromyographic (EMG) signals will be recorded bilaterally from seven muscles (tibialis anterior, soleus, lateral gastrocnemius, rectus femoris, biceps femoris, semimembranosus, gluteus medius) (Delsys, Trigno) at 1000 Hz and synchronized to whole body kinematics (8-camera motion capture system, SIMI Inc. or Qualisys Inc.) collected at 100 or 120 Hz and with 128-channels of EEG data (BioSemi, Amsterdam) collected at 2000 Hz according to the 10:20 international system 35 . Additionally, resting-state EEG will be collected, to reference and remove walking artifact 36 . Local field potentials (LFPs) will be recorded on the Medtronic Percept system and synchronized to the other data collection systems by briefly turning the device on and off. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madison Aasen, MS | Contact | 612-505-8325 | aasen056@umn.edu | |
| Sommer Amundsen-Huffmaster, PhD | Contact | 612-301-1297 | slamunds@umn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota, Movement Disorders Lab | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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In the second experiment: we will compare LFPs during the successful movement transitions vs. freezing-events during a FOG provocation course in people with FOG only.
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| OFF Deep Brain Stimulation | Other | Participants will have their deep brain stimulation turned off at the beginning of their testing visit. |
|
| During the intervention |
| Step characteristics of the first two steps, duration (sec) | Blocks of 10 successful step initiation trials will be performed. Ground reaction forces (Kistler Inc.) and bipolar surface electromyographic (EMG) signals will be recorded bilaterally from seven muscles (tibialis anterior, soleus, lateral gastrocnemius, rectus femoris, biceps femoris, semimembranosus, gluteus medius) (Delsys, Trigno) at 1000 Hz and synchronized to whole body kinematics (8-camera motion capture system, SIMI Inc. or Qualisys Inc.) collected at 100 or 120 Hz and with 128-channels of EEG data (BioSemi, Amsterdam) collected at 2000 Hz according to the 10:20 international system 35 . Additionally, resting-state EEG will be collected, to reference and remove walking artifact 36 . Local field potentials (LFPs) will be recorded on the Medtronic Percept system and synchronized to the other data collection systems by briefly turning the device on and off. | During the intervention |
| The coherence magnitudes between the cortex and globus pallidus (dB) | Blocks of 10 successful step initiation trials will be performed. Ground reaction forces (Kistler Inc.) and bipolar surface electromyographic (EMG) signals will be recorded bilaterally from seven muscles (tibialis anterior, soleus, lateral gastrocnemius, rectus femoris, biceps femoris, semimembranosus, gluteus medius) (Delsys, Trigno) at 1000 Hz and synchronized to whole body kinematics (8-camera motion capture system, SIMI Inc. or Qualisys Inc.) and with 128-channels of EEG data (BioSemi, Amsterdam) collected at 2000 Hz according to the 10:20 international system 35. Additionally, resting-state EEG will be collected, to reference and remove walking artifact 36. Local field potentials (LFPs) will be recorded on the Medtronic Percept system and synchronized to the other data collection systems by briefly turning the device on and off. Coherence will be calculated between the cortex and basal ganglia, and the magnitudes will be calculated at different frequencies (power, decibels, dB). | During the intervention |
| The coherence magnitudes between the cortex and EMG (dB) | Blocks of 10 successful step initiation trials will be performed. Ground reaction forces (Kistler Inc.) and bipolar surface electromyographic (EMG) signals will be recorded bilaterally from seven muscles (tibialis anterior, soleus, lateral gastrocnemius, rectus femoris, biceps femoris, semimembranosus, gluteus medius) (Delsys, Trigno) at 1000 Hz and synchronized to whole body kinematics (8-camera motion capture system, SIMI Inc. or Qualisys Inc.) and with 128-channels of EEG data (BioSemi, Amsterdam) according to the 10:20 international system 35 . Additionally, resting-state EEG will be collected, to reference and remove walking artifact 36 . Local field potentials (LFPs) will be recorded on the Medtronic Percept system and synchronized to the other data collection systems by briefly turning the device on and off. Coherence will be calculated between the cortex and the muscle activity, and the magnitudes will be calculated at different frequencies (power, decibels, dB). | During the intervention |
| The coherence magnitudes between the globus pallidus and EMG (dB) | Blocks of 10 successful step initiation trials will be performed. Ground reaction forces (Kistler Inc.) and bipolar surface electromyographic (EMG) signals will be recorded bilaterally from seven muscles (tibialis anterior, soleus, lateral gastrocnemius, rectus femoris, biceps femoris, semimembranosus, gluteus medius) (Delsys, Trigno) at 1000 Hz and synchronized to whole body kinematics (8-camera motion capture system, SIMI Inc. or Qualisys Inc.) and with 128-channels of EEG data (BioSemi, Amsterdam) according to the 10:20 international system 35 . Additionally, resting-state EEG will be collected, to reference and remove walking artifact 36 . Localfield potentials (LFPs) will be recorded on the Medtronic Percept system and synchronized to the other data collection systems by briefly turning the device on and off. Coherence will be calculated between the globus pallidus and the muscle activity, and the magnitudes will be calculated at different frequencies (power, decibels, dB). | During the intervention |
| Number of freezing episodes | Kinematics will be measured using 6 inertial measurement units (IMUs, Opal sensors, APDM), containing triaxial accelerometers, gyro-scopes, and magnetometers, on each foot and wrist, the fifth lumbar vertebra, and the sternum. This system has been validated for use in PD gait to provide measures of gait (velocity, stride length mean and SD, cadence, and stride time mean and SD), gait initiation (measures of APA and 1 st step characteristics) and turning. Kinematic data will be collected at 128 Hz and synchronized to video recordings and LFP data. LFP and kinematic data will be classified by transition type: initiation, turning, and doorways, and compared during successful transitions, and freezing episodes (unsuccessful transitions). Number of freezing episodes will be identified and rated qualitatively from the videotape by a blinded rater. | During the intervention |
| Rapid Alternating Movements of Wrist Pronation/Supination (degrees) | Participants will perform rapid alternating movements of the wrist or ankle while a manipulandum measures their angular position, with EMG of the moving limb, EEG and LFPs are recorded synchronously. Movements will be cued using a series of beeps that will change randomly between a low and a high- frequency. RMS of the amplitude will be calculated. | During the intervention |
| Rapid Alternating Movements of Supination or Ankle plantar/dorsi-flexion (degrees) | Participants will perform rapid alternating movements of the wrist or ankle while a manipulandum measures their angular position, with EMG of the moving limb, EEG and LFPs are recorded synchronously. Movements will be cued using a series of beeps that will change randomly between a low and a high- frequency. RMS of the amplitude will be calculated. | During the intervention |
| Peak power of local field potential oscillations (dB) | Average changes in peak alpha and beta power derived from power spectral density analysis of the local field potential signal recorded by the implanted Medtronic Percept™ device. | During the intervention |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |