Parkinson DiseaseFOG-EEGNCT06841718
Investigating the Neural Signature of Freezing of Gait in Parkinson's Disease
An observational study of Parkinson Disease and Freezing of Gait, run by KU Leuven at 1 site in Belgium.
Trial summary
Freezing of Gait (FOG) is a disabling symptom of Parkinson's disease (PD) and a leading cause for falls. Current medical management is inadequate to alleviate FOG so there is need for improved treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Freezing of Gait, Basal Ganglia Diseases
- How many people
- 28 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Nov 2024to Sep 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with Parkinson's Disease who self-report to experience FOG more than once a day.
Who may be able to join
- Clinical diagnosis of Parkinson's disease (PD) made by a Neurologist*
- Modified Hoehn \& Yahr (H\&Y) Stage I to IV in the ON medication state
- Age above 18 years*
- Able to walk 5 minutes while unassisted by a walker or another person (the use of a cane is allowed).*
- Mini Mental State Examination>= 21
- At least three hours in-between regular medication intakes to allow for stable testing time.*
- Self-reported FOG with a severity of at least 1 FOG episode per day, based on items 1 and 2 of the New Freezing of Gait Questionnaire, irrespective of FOG occurring ON- or OFF-medication.*
- Stable medication scheme for at least 7 days before enrollment.
Who cannot join
- Participation in another clinical intervention study*
- Acute musculoskeletal or other neurological, psychiatric, or cardiovascular conditions affecting gait or any other medical condition which, in the opinion of the investigator, may prevent the participant from completing the protocol in full
- Unable to adhere to assessment procedures leading to missing or unusable data, as determined by the investigators
- Not a stable medication scheme for at least 7 days before the assessment.*
- Occurrence of any of the following within 3 months prior to informed consent:
- Orthopedic surgery of the lower extremity
Show all 13Show fewer
- Myocardial infarction
- Hospitalization for unstable angina
- Coronary artery bypass graft
- Percutaneous coronary intervention
- Implantation of a cardiac resynchronization therapy device
- Implantation of deep brain stimulation
- Substance abuse that may interfere with the patient's compliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigating the Neural Signature of Freezing of Gait Using Ambulatory Electroencephalography in Parkinson's Disease
Freezing of Gait (FOG) is a disabling symptom of Parkinson's disease (PD) and a leading cause for falls. Current medical management is inadequate to alleviate FOG so there is need for improved treatments. A major draw-back in the development of better treatments for FOG is the difficulty in detecting episodes and our poor understanding of its underlying pathophysiology.
This study will investigate the cortical signature of FOG using ambulatory electroencephalography (EEG) to help improve FOG detection algorithms and provide novel insights into the underlying pathophysiology, which together will guide therapy development.
- Conditions
- Parkinson Disease, Freezing of Gait, Basal Ganglia Diseases, Brain Disease, Movement Disorders, Neurodegenerative Disease
- Keywords
- Parkinson's Disease, electroencephalography (EEG), freezing of gait, gait problems
- Medical subject headings
- Parkinson Disease, Basal Ganglia Diseases, Brain Diseases, Movement Disorders, Neurodegenerative Diseases, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Home assessment | All 28 participants will undergo a single home based assessment including a gait protocol as well as administering clinimetrics and questionnaires. Patients will be tested early in the morning after at least 12 hours without the anti-parkinsonian medication (= 'partial' OFF medication) and then about 1 hour after the intake of the first morning medication dose, when the subject reports reaching self-reported ON state (= ON medication). The gait protocol consist out of A) a trajectory in the participants home from the living room towards the bathroom and back, including a 360° turn as well as a figure-8 turn and going through a doorway and B) a daily living task. All tests will be conducted in a fixed order. The protocol will be conducted as a single task, with a dual task (serial subtraction task), with voluntary stops during different parts of the trajectory, and with an auditory cue (rhythm set 10% slower then typical cadence). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Power spectral density (Watts/hertz) of beta frequencies
The averaged power spectral density (PSD) of the beta (12-25 Hz) frequency band measured over the motor cortices during freezing of gait (FOG) episodes compared to typical gait performance in the same individual with Parkinson's disease as measured during different walking trajectories in the home setting.
Measured: During walking protocol (duration 15-20 minutes)
Secondary outcomes (3)
Power spectral density (Watts/hertz) of theta frequencies bands
The averaged power spectral density (PSD) of the theta (4-7 Hz) frequency band measured over the prefrontal cortices during freezing of gait (FOG) episodes compared to typical gait performance in the same individual with Parkinson's disease as measured during different walking trajectories in the home setting.
Measured: During walking protocol (duration 15-20 minutes)
Cross-frequency coupling between beta and theta frequency bands
The averaged cross-frequency coupling (CFC) between the beta (12-25 Hz) and theta (4-7 Hz) frequency bands as measured over the motor and prefrontal cortices during freezing of gait (FOG) episodes compared to typical gait performance in the same individual with Parkinson's disease as measured during different walking trajectories in the home setting.
Measured: During walking protocol (duration 15-20 minutes)
Power spectral density (Watts/hertz) and cross-frequency coupling (CFC) of beta and theta frequencies bands over other cortical areas.
The averaged power spectral density (PSD) of the beta (12-25 Hz) and theta (4-7 Hz) frequency band measured over other cortical areas (prefrontal, motor, temporal, parietal, visual) during freezing of gait (FOG) episodes compared to typical gait performance in the same individual with Parkinson's disease as measured during different walking trajectories in the home setting.
Measured: During walking protocol (duration 15-20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start4 Nov 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moran Gilat, KU Leuven
- Investigators
- Moran Gilat, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841718
- Sponsor's protocol ID
- s69013
- Acronym
- FOG-EEG
- Status last verified
- Feb 2025
- First submitted
- 27 Jan 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets could be made available under restricted access after publication of the results, following ethical approval and a data-transfer agreement. GDPR and privacy regulations will be adhered to.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Neural Signature of Freezing of Gait Using Ambulatory Electroencephalography in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06841718
- Acronym / sponsor ID
- FOG-EEG / s69013
- Conditions
- Parkinson Disease, Freezing of Gait, Basal Ganglia Diseases, Brain Disease, Movement Disorders, Neurodegenerative Disease
- Keywords
- Parkinson's Disease, electroencephalography (EEG), freezing of gait, gait problems
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 24 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.
Freezing of Gait (FOG) is a disabling symptom of Parkinson's disease (PD) and a leading cause for falls. Current medical management is inadequate to alleviate FOG so there is need for improved treatments. A major draw-back in the development of better treatments for FOG is the difficulty in detecting episodes and our poor understanding of its underlying pathophysiology.
This study will investigate the cortical signature of FOG using ambulatory electroencephalography (EEG) to help improve FOG detection algorithms and provide novel insights into the underlying pathophysiology, which together will guide therapy development.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home assessment | – | –All 28 participants will undergo a single home based assessment including a gait protocol as well as administering clinimetrics and questionnaires. Patients will be tested early in the morning after at least 12 hours without the anti-parkinsonian medication (= 'partial' OFF medication) and then about 1 hour after the intake of the first morning medication dose, when the subject reports reaching self-reported ON state (= ON medication). The gait protocol consist out of A) a trajectory in the participants home from the living room towards the bathroom and back, including a 360° turn as well as a figure-8 turn and going through a doorway and B) a daily living task. All tests will be conducted in a fixed order. The protocol will be conducted as a single task, with a dual task (serial subtraction task), with voluntary stops during different parts of the trajectory, and with an auditory cue (rhythm set 10% slower then typical cadence). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with Parkinson's Disease who self-report to experience FOG more than once a day.
Key inclusion criteria (8 listed)
- Clinical diagnosis of Parkinson's disease (PD) made by a Neurologist*
- Modified Hoehn \& Yahr (H\&Y) Stage I to IV in the ON medication state
- Age above 18 years*
- Able to walk 5 minutes while unassisted by a walker or another person (the use of a cane is allowed).*
- Mini Mental State Examination>= 21
Key exclusion criteria (13 listed)
- Participation in another clinical intervention study*
- Acute musculoskeletal or other neurological, psychiatric, or cardiovascular conditions affecting gait or any other medical condition which, in the opinion of the investigator, may prevent the participant from completing the protocol in full
- Unable to adhere to assessment procedures leading to missing or unusable data, as determined by the investigators
- Not a stable medication scheme for at least 7 days before the assessment.*
- Occurrence of any of the following within 3 months prior to informed consent:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Power spectral density (Watts/hertz) of beta frequencies
Time frame: During walking protocol (duration 15-20 minutes)
The averaged power spectral density (PSD) of the beta (12-25 Hz) frequency band measured over the motor cortices during freezing of gait (FOG) episodes compared to typical gait performance in the same individual with Parkinson's disease as measured during different walking trajectories in the home setting.
3 secondary outcomes
Power spectral density (Watts/hertz) of theta frequencies bands
Time frame: During walking protocol (duration 15-20 minutes)
Cross-frequency coupling between beta and theta frequency bands
Time frame: During walking protocol (duration 15-20 minutes)
Power spectral density (Watts/hertz) and cross-frequency coupling (CFC) of beta and theta frequencies bands over other cortical areas.
Time frame: During walking protocol (duration 15-20 minutes)
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 24 Feb 2025.
- Individual participant dataSharing planned: Undecided. The datasets could be made available under restricted access after publication of the results, following ethical approval and a data-transfer agreement. GDPR and privacy regulations will be adhered to.
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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.
Moran Gilat, PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Freezing of Gait, run by KU Leuven at 1 site in Belgium.
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 13 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: enrolling by invitation, as of the sponsor's last update on 24 Feb 2025. 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 Belgium. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Power spectral density (Watts/hertz) of beta frequencies (time frame: During walking protocol (duration 15-20 minutes)). 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 24 Feb 2025.