Gait Disorders, NeurologicFlicker w FOGNCT06295458
Gamma Sensory Flicker for Parkinson's Disease Patients With Freezing of Gait
A study testing David Delight Plus Device in people with Gait Disorders, Neurologic and Parkinson Disease, run by Emory University at 1 site in United States.
Trial summary
This study aims to answer the question: to assess the safety, and tolerability of gamma light in Parkinson's disease (PD) patients with freezing of gait (FOG). Parkinson's disease (PD) patients often experience a complex gait disorder known as Freezing of Gait (FOG). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Gait Disorders, Neurologic, Parkinson Disease
- What is being tested?
- David Delight Plus Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2024to 4 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PD Diagnosis by UK Brain Bank Criteria
- Hoehn \& Yahr stage I-IV in the off-state
- FOG noted in medical history
- FOG confirmed visually by the examiner in the office
- PD that is levodopa-treated and responsive
- Able to manage 12 hours of "OFF" dopaminergic medication state
- Age 50-80 years
- Able to sign a consent document and willing to participate in all aspects of the study
Who cannot join
- A diagnosis of atypical Parkinsonism, including vascular Parkinsonism
- Prior treatment with medications that cause Parkinsonism
- Stage V PD -unable to walk independently when OFF
- Absence of levodopa response
- Neurological or orthopedic disorders interfering with gait
- Dementia precluding completing the study protocol, including those meeting criteria for dementia with Lewy bodies
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- Major depression based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
- Any medical problems that would preclude participation, including individuals with a history of migraines, tinnitus, or seizures, because sensory stimuli can potentially exacerbate these conditions.
- Profound sensory loss as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory Movement Disorders Center
Atlanta, Georgia, 30329
About this study
This study aims to answer the question: to assess the safety, and tolerability of gamma light in Parkinson's disease (PD) patients with freezing of gait (FOG).
Parkinson's disease (PD) patients often experience a complex gait disorder known as Freezing of Gait (FOG). FOG is characterized by brief arrests of stepping when initiating gait, turning, and walking straight and patients describe it as their feet being "glued" to the floor. FOG in Parkinson's disease (PD) is a considerable public health burden worldwide. It is a poorly understood gait symptom that has potentially grave consequences as FOG is intermittent and unpredictable, a leading cause of falls with injury, and results in loss of independence. FOG is generally found to be associated with cognitive decline, particularly executive dysfunction which, in turn, has been associated with higher spinal fluid amyloid (Aβ42) levels in PD.
There is data linking amyloid to FOG. A previous study showed that the gamma light helped reduce some amyloid. The research team is studying if gamma light exposure for 1 hour daily is well tolerated. Also, does it have any effect on freezing of gait severity?
Read the detailed description
This will be a sham-controlled study with one group receiving the sensory stimulation and the other receiving sham stimulation.
Exposure will be provided by wearing a pair of glasses and headphones. Both of these will be connected to a device that will provide light and sound during the daily 1-hour session.
Gamma light appeared in a previous study to have potential as a non-invasive, non-medication approach to reduce amyloid from the brain. This study will investigate if the link between amyloid and FOG can be changed and improve FOG.
Gamma is a short wavelength of light and/or sound between 25-140Hz. Previous research suggested that 40Hz can potentially activate cells in the brain to remove amyloid. Amyloid is a protein that forms in the spaces between nerve cells in the brain in diseases such as Alzheimer's and Parkinson's disease.
This study also has two optional parts. One option is to undergo two lumbar punctures at the baseline and Month 6 visits. The other option is to participate in a one-year extension of the study. Blood draws will be used to verify levodopa levels in the blood during both the ON and OFF Parkinson's disease medication states.
Optional lumbar punctures will be performed at baseline and 6 months to collect cerebrospinal fluid (CSF) samples which will be analyzed for change in amyloid levels before and after treatment. An electroencephalogram (EEG) will be utilized at the beginning of the study to evaluate the brain's response to the stimulus. Cognitive testing will be administered to capture any cognitive changes. Questionnaires used will provide any changes to the participant's self-evaluation.
The duration of the blinded portion is approximately 7 months. The optional extension portion will have two in-clinic visits at month 12 and month 18. Participants will be enrolled from the Emory University movement disorder clinic.
- Conditions
- Gait Disorders, Neurologic, Parkinson Disease
- Being tested
- David Delight Plus Device, Sham Therapy
- Keywords
- Freezing of Gait (FOG), Amyloid, Gamma Flicker, Parkinson's disease
- Medical subject headings
- Gait Disorders, Neurologic, Parkinson Disease, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
David Delight Plus DeviceDevice
Also called Flicker Device, Intervention Group
Flicker exposure via a light and sound device-based stimulation-provided sensory stimulation device. The DAVID Delight Plus device consists of light-emitting goggles and sound-emitting headphones that are turned on and off with a repetition rate of 40 Hz connected to a controller operated by the participant or study partner (if the participant elects to have an optional study partner). At the baseline visit, light and sound intensity levels (auditory: 0-80 dBA, visual: 0-1400 lux) will be programmed into each participant's controller based on their unique response to tolerance and EEG entrainment testing which occurred at screening. The participant may not detect gamma-flicker frequency.
Sham TherapyOther
Also called Control Group
Sham therapy will be provided in the same manner as the flicker light. The difference is that it will be a constant light and sound from the same device instead of the 40hz light treatment and sound.
| Study group | Role | What they receive |
|---|---|---|
| Flicker Exposure (Treatment Group) | Experimental | Participants will be instructed to take home the stimulation equipment. Participants and their study partners (if applicable) will be trained on how to use the device before leaving the facility. Each device case also includes an instruction document. Participants and/or study partners (if applicable) will keep a manual log of daily operation, including the time of day used, whether the participant felt drowsy or, was able to complete the entire session, or if the participant was unable to complete the therapy that day. Finally, study staff will contact participants monthly every 2 weeks to ensure compliance, assess adverse events, and log concomitant medications. Receives: Device: David Delight Plus Device |
| Control Group | Sham comparator | Participants will receive sham stimulation. Participants and/or study partners (if applicable) will keep a manual log of daily operation, including the time of day used, whether the participant felt drowsy or, was able to complete the entire session, or if the participant was unable to complete the therapy that day. Finally, study staff will contact participants monthly every 2 weeks to ensure compliance, assess adverse events, and log concomitant medications. Receives: Other: Sham Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse events
Participants will document the occurrence of any adverse events that occur during the flicker exposure to evaluate the safety and tolerability.
Measured: up to 6 months
Number of participants compliant with the study procedures
Compliance will be measured by the number of participants who adhere to the study procedures (at-home usage, monitored by the device, and manual log of daily operation by the participants and their study partners).
Measured: up to 6 months
Secondary outcomes (3)
Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scale in participants with PD
Each participant with PD will be assessed at baseline and at 6 months in the practically defined off state and after a levodopa challenge with the MDS-UPDRS scale. The MDS-UPDRS was developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. It includes a motor evaluation and characterizes the extent and burden of disease. Each Parkinsonian sign or symptom is rated on a 5-point Likert-type scale (ranging from 0 to 4), with higher scores indicating more severe impairment. The maximum total UPDRS score is 199, indicating the worst possible disability from PD. The change in severity based on both measures will be compared between groups.
Measured: Baseline and up to 6 months
Change in the freezing of gait severity in participants with PD.
Each participant with PD will be assessed at baseline and at 6 months in the practically defined off state and after a levodopa challenge with MDS-UPDRS scale and in the motion capture laboratory to assess percent time with freezing during timed up and go tests. The change in severity based on both measures will be compared between groups.
Measured: Baseline and up to 6 months
Change in subjective changes in FOG.
Participants will complete the New Freezing of Gait Questionnaire (N-FOGQ) to assess subjective changes in FOG. The NFOG-Q is in essence a valid, self-reported questionnaire assessing the clinical aspects of freezing (frequency and duration) and its impact on quality of life when looking back during a period of 1 month. The total score ranges between 0 and 28 points and requires a rating of FOG occurrence in both on or off-medication states. Higher scores correspond to more severe FOG.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start8 Jul 2024
- Primary completion4 May 2026
- Study completion4 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Disorders, NeurologicStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Parkinson's Foundation
- Responsible party
- Principal investigator, Stewart Factor, Emory University
- Investigators
- Stewart Factor, DO, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295458
- Sponsor's protocol ID
- STUDY00006945
- Other IDs
- 2025P010746
- Acronym
- Flicker w FOG
- Status last verified
- Jul 2026
- First submitted
- 22 Jan 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All deidentified tabular data will be shared in the format of a CSV download of the study Redcap database. The Research Team will also provide the accompanying data dictionary.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamma Sensory Flicker for Parkinson's Disease Patients With Freezing of Gait
- ClinicalTrials.gov ID
- NCT06295458
- Acronym / sponsor ID
- Flicker w FOG / STUDY00006945
- Conditions
- Gait Disorders, Neurologic, Parkinson Disease
- Keywords
- Freezing of Gait (FOG), Amyloid, Gamma Flicker, Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Parkinson's Foundation
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 6 Mar 2024 (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.
This study aims to answer the question: to assess the safety, and tolerability of gamma light in Parkinson's disease (PD) patients with freezing of gait (FOG).
Parkinson's disease (PD) patients often experience a complex gait disorder known as Freezing of Gait (FOG). FOG is characterized by brief arrests of stepping when initiating gait, turning, and walking straight and patients describe it as their feet being "glued" to the floor. FOG in Parkinson's disease (PD) is a considerable public health burden worldwide. It is a poorly understood gait symptom that has potentially grave consequences as FOG is intermittent and unpredictable, a leading cause of falls with injury, and results in loss of independence. FOG is generally found to be associated with cognitive decline, particularly executive dysfunction which, in turn, has been associated with higher spinal fluid amyloid (Aβ42) levels in PD.
There is data linking amyloid to FOG. A previous study showed that the gamma light helped reduce some amyloid. The research team is studying if gamma light exposure for 1 hour daily is well tolerated. Also, does it have any effect on freezing of gait severity?
Detailed description
This will be a sham-controlled study with one group receiving the sensory stimulation and the other receiving sham stimulation.
Exposure will be provided by wearing a pair of glasses and headphones. Both of these will be connected to a device that will provide light and sound during the daily 1-hour session.
Gamma light appeared in a previous study to have potential as a non-invasive, non-medication approach to reduce amyloid from the brain. This study will investigate if the link between amyloid and FOG can be changed and improve FOG.
Gamma is a short wavelength of light and/or sound between 25-140Hz. Previous research suggested that 40Hz can potentially activate cells in the brain to remove amyloid. Amyloid is a protein that forms in the spaces between nerve cells in the brain in diseases such as Alzheimer's and Parkinson's disease.
This study also has two optional parts. One option is to undergo two lumbar punctures at the baseline and Month 6 visits. The other option is to participate in a one-year extension of the study. Blood draws will be used to verify levodopa levels in the blood during both the ON and OFF Parkinson's disease medication states.
Optional lumbar punctures will be performed at baseline and 6 months to collect cerebrospinal fluid (CSF) samples which will be analyzed for change in amyloid levels before and after treatment. An electroencephalogram (EEG) will be utilized at the beginning of the study to evaluate the brain's response to the stimulus. Cognitive testing will be administered to capture any cognitive changes. Questionnaires used will provide any changes to the participant's self-evaluation.
The duration of the blinded portion is approximately 7 months. The optional extension portion will have two in-clinic visits at month 12 and month 18. Participants will be enrolled from the Emory University movement disorder clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flicker Exposure (Treatment Group) | Experimental | Device: David Delight Plus DeviceParticipants will be instructed to take home the stimulation equipment. Participants and their study partners (if applicable) will be trained on how to use the device before leaving the facility. Each device case also includes an instruction document. Participants and/or study partners (if applicable) will keep a manual log of daily operation, including the time of day used, whether the participant felt drowsy or, was able to complete the entire session, or if the participant was unable to complete the therapy that day. Finally, study staff will contact participants monthly every 2 weeks to ensure compliance, assess adverse events, and log concomitant medications. |
| Control Group | Sham comparator | Other: Sham TherapyParticipants will receive sham stimulation. Participants and/or study partners (if applicable) will keep a manual log of daily operation, including the time of day used, whether the participant felt drowsy or, was able to complete the entire session, or if the participant was unable to complete the therapy that day. Finally, study staff will contact participants monthly every 2 weeks to ensure compliance, assess adverse events, and log concomitant medications. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- PD Diagnosis by UK Brain Bank Criteria
- Hoehn \& Yahr stage I-IV in the off-state
- FOG noted in medical history
- FOG confirmed visually by the examiner in the office
- PD that is levodopa-treated and responsive
Key exclusion criteria (9 listed)
- A diagnosis of atypical Parkinsonism, including vascular Parkinsonism
- Prior treatment with medications that cause Parkinsonism
- Stage V PD -unable to walk independently when OFF
- Absence of levodopa response
- Neurological or orthopedic disorders interfering with gait
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 |
|---|---|---|
| David Delight Plus DeviceAlso: Flicker Device, Intervention GroupFlicker exposure via a light and sound device-based stimulation-provided sensory stimulation device. The DAVID Delight Plus device consists of light-emitting goggles and sound-emitting headphones that are turned on and off with a repetition rate of 40 Hz connected to a controller operated by the participant or study partner (if the participant elects to have an optional study partner). At the baseline visit, light and sound intensity levels (auditory: 0-80 dBA, visual: 0-1400 lux) will be programmed into each participant's controller based on their unique response to tolerance and EEG entrainment testing which occurred at screening. The participant may not detect gamma-flicker frequency. | Device | Flicker Exposure (Treatment Group) |
| Sham TherapyAlso: Control GroupSham therapy will be provided in the same manner as the flicker light. The difference is that it will be a constant light and sound from the same device instead of the 40hz light treatment and sound. | Other | Control Group |
Primary outcome
Number of participants with Adverse events
Time frame: up to 6 months
Participants will document the occurrence of any adverse events that occur during the flicker exposure to evaluate the safety and tolerability.
Number of participants compliant with the study procedures
Time frame: up to 6 months
Compliance will be measured by the number of participants who adhere to the study procedures (at-home usage, monitored by the device, and manual log of daily operation by the participants and their study partners).
3 secondary outcomes
Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scale in participants with PD
Time frame: Baseline and up to 6 months
Change in the freezing of gait severity in participants with PD.
Time frame: Baseline and up to 6 months
Change in subjective changes in FOG.
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Yes. All deidentified tabular data will be shared in the format of a CSV download of the study Redcap database. The Research Team will also provide the accompanying data dictionary.
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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. This study is not recruiting at the moment.
Stewart Factor, DO principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing David Delight Plus Device in people with Gait Disorders, Neurologic and Parkinson Disease, run by Emory University 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 9 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: finished, as of the sponsor's last update on 4 Aug 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with Adverse events (time frame: up to 6 months). The study lists 2 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 4 Aug 2026.