Percept Transitions in FOG and PD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorUniversity of Minnesota
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of idiopathic PD.
Age 21-75 (see Inclusion of Individuals across the Lifespan for justification of age range).
Able to ambulate independently without the use of an assistive device (e.g. cane) for 50 meters.
Implanted Medtronic Percept TM Device.
Disqualifiers
Meet criteria for dementia with Lewy bodies, Multiple Systems Atrophy, Alzheimer's disease, or other neurodegenerative disorder.
History of seizures or other significant neurological disorders that may affect participation or performance in the study.
History of musculoskeletal disorders that significantly affect walking or movement of limb(s) that would affect the participation in the experimental task (Participants will be excluded from that task, but may participate in other tasks, for example, may be excluded from Experiment 1 if the disorder affects walking, but may still participate in Experiment 3).
History of muscular conditions of the neck and back, including whiplash that would affect walking experiments.
Trial design
Design model
Parallel
Treatments tested in this trial
OFF Parkinson's Medication(s)
Other interventionParticipants 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).
OFF Deep Brain Stimulation
Other interventionParticipants will have their deep brain stimulation turned off at the beginning of their testing visit.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Parkinson's disease with freezing of gaitExperimental treatment 2 interventions
Group B: Parkinson's disease without freezing of gaitExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
During the intervention2
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.
Time frame
During the intervention3
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.
Time frame
During the intervention4
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.
Time frame
During the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Minnesota
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov