Freezing of GaitNCT06848205
Percept Transitions in FOG and PD
A study testing OFF Parkinson's Medication(s) and OFF Deep Brain Stimulation in people with Freezing of Gait and Parkinson Disease, run by University of Minnesota at 1 site in United States.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Freezing of Gait, Parkinson Disease
- What is being tested?
- OFF Parkinson's Medication(s) and OFF Deep Brain Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2026to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- At least 3 months since the initial activation of the neurostimulator.
- Undervalued, under-represented, or disenfranchised social group may be included.
- Active members of the military (service members), DoD personnel (including civilian employees) may be included.
- Individual or group that is disadvantaged in the distribution of social goods and services such as income, housing, or healthcare may be included.
Who cannot join
- 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.
- History of visual and/or vestibular conditions that may affect participation or performance in the study.
- Reduced capacity to consent. This will be assessed using a 2-stage process. Initially, participants will be tested using the University of California, San Diego, Brief Assessment of Capacity to Consent (UBACC). If concerns are raised from the UBACC test, the individual will be further tested using the MacArthur Competency Assessment Tool.
- Pregnant people.
- Post-operative complications or adverse effects (e.g. ON stimulation dystonia) that affect patient safety or confound the experiment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota, Movement Disorders Lab
Minneapolis, Minnesota, 55455
Madison Aasen, MS, 612-505-8325, aasen056@umn.edu
Sommer Amundsen-Huffmaster, PhD
About this study
Official title: Basal Ganglia Contributions to Transitions in Freezing of Gait and Parkinson's Disease
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).
Read more
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
Read the detailed description
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.
- Conditions
- Freezing of Gait, Parkinson Disease
- Being tested
- OFF Parkinson's Medication(s), OFF Deep Brain Stimulation
- Keywords
- FOG, PD, Freezing of Gait, Parkinson disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
OFF Deep Brain StimulationOther
Participants will have their deep brain stimulation turned off at the beginning of their testing visit.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: OFF Parkinson's Medication(s); Other: OFF Deep Brain Stimulation |
| 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. Receives: Other: OFF Parkinson's Medication(s); Other: OFF Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start26 Feb 2026
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Freezing of GaitStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848205
- Sponsor's protocol ID
- NEUR-2024-33357
- Other IDs
- STUDY00023279
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basal Ganglia Contributions to Transitions in Freezing of Gait and Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06848205
- Acronym / sponsor ID
- NEUR-2024-33357
- Conditions
- Freezing of Gait, Parkinson Disease
- Keywords
- FOG, PD, Freezing of Gait, Parkinson disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease with freezing of gait | Experimental | Other: OFF Parkinson's Medication(s), Other: OFF Deep Brain StimulationParticipants will have a Medtronic Percept DBS device, diagnosis of idiopathic Parkinson's disease (PD), and freezing of gait (FOG). |
| Parkinson's disease without freezing of gait | Experimental | Other: OFF Parkinson's Medication(s), Other: OFF Deep Brain StimulationParticipants 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- At least 3 months since the initial activation of the neurostimulator.
Key exclusion criteria (8 listed)
- 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.
- History of visual and/or vestibular conditions that may affect participation or performance in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OFF Parkinson's Medication(s)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). | Other | Parkinson's disease with freezing of gait, Parkinson's disease without freezing of gait |
| OFF Deep Brain StimulationParticipants will have their deep brain stimulation turned off at the beginning of their testing visit. | Other | Parkinson's disease with freezing of gait, Parkinson's disease without freezing of gait |
Primary outcome
Quantification of the anticipatory postural adjustments magnitudes (cm)
Time frame: During the intervention
Blocks of 10 successful step initiation trials will be performed. Ground reaction forces (Kistler Inc.) will be recorded.
Quantification of the anticipatory postural adjustments duration (sec)
Time frame: During the intervention
Blocks of 10 successful step initiation trials will be performed. Ground reaction forces (Kistler Inc.) will be recorded.
Step characteristics of the first two steps, length (cm)
Time frame: During the intervention
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.
Step characteristics of the first two steps, width (cm)
Time frame: During the intervention
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.
Step characteristics of the first two steps, duration (sec)
Time frame: During the intervention
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.
The coherence magnitudes between the cortex and globus pallidus (dB)
Time frame: During the intervention
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).
The coherence magnitudes between the cortex and EMG (dB)
Time frame: During the intervention
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).
The coherence magnitudes between the globus pallidus and EMG (dB)
Time frame: During the intervention
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).
Number of freezing episodes
Time frame: During the intervention
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.
Rapid Alternating Movements of Wrist Pronation/Supination (degrees)
Time frame: During the intervention
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.
Rapid Alternating Movements of Supination or Ankle plantar/dorsi-flexion (degrees)
Time frame: During the intervention
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.
Peak power of local field potential oscillations (dB)
Time frame: During the intervention
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OFF Parkinson's Medication(s) and OFF Deep Brain Stimulation in people with Freezing of Gait and Parkinson Disease, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madison Aasen, MS (612-505-8325, aasen056@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of the anticipatory postural adjustments magnitudes (cm) (time frame: During the intervention). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.