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Lo studio clinico NCT06295458 (Flicker w FOG) per Disturbi dell'andatura neurologici, Malattia di Parkinson è attivo, non in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Università EmoryGamma Sensory Flicker for Parkinson's Disease Patients With Freezing of Gait (Flicker w FOG) 24
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La sperimentazione clinica NCT06295458 (Flicker w FOG) è uno studio interventistico per Disturbi dell'andatura neurologici, Malattia di Parkinson, attualmente attivo, non in arruolamento. Avviato il 8 luglio 2024, prevede di arruolare 24 partecipanti. Sotto la guida di l'Università Emory, dovrebbe concludersi entro il 1 giugno 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 5 marzo 2026.
Sommario breve
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 "glu...
Mostra di piùDescrizione dettagliata
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 red...
Mostra di piùTitolo ufficiale
Gamma Sensory Flicker for Parkinson's Disease Patients With Freezing of Gait
Patologie
Disturbi dell'andatura neurologiciMalattia di ParkinsonAltri ID dello studio
- Flicker w FOG
- STUDY00006945
- 2025P010746 (Altro identificativo) (Emory Insight Humans IRB)
Numero NCT
Data di inizio (effettiva)
2024-07-08
Ultimo aggiornamento pubblicato
2026-03-05
Data di completamento (stimata)
2027-06
Arruolamento (previsto)
24
Tipo di studio
Interventistico
FASE
N.D.
Stato
Attivo, non in arruolamento
Parole chiave
Freezing of Gait (FOG)
Amyloid
Gamma Flicker
Parkinson's disease
Amyloid
Gamma Flicker
Parkinson's disease
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Triplo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleFlicker Exposure (Treatment Group) 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, wa...Mostra di più | David Delight Plus Device 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 an...Mostra di più |
Comparatore simulatoControl Group 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 adve...Mostra di più | Terapia Simulata 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. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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. | 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). | up to 6 months |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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. | 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. | 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. | Baseline and 6 months |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
50 Years
Sessi idonei
Tutti
- 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
- 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
- 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.
Università Emory398 studi clinici attivi da esplorareParkinson's FoundationParte responsabile dello studio
Stewart Factor, Investigatore principale, Principal Investigator, Emory University
Nessun dato di contatto
1 Centri dello studio in 1 paesi
Georgia
Emory Movement Disorders Center, Atlanta, Georgia, 30329, United States