Revitalize Cognition: Near Infrared Stimulation in Parkinson Patients

NACompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

June 26, 2019

Primary Completion Date

February 17, 2021

Study Completion Date

August 15, 2022

Conditions
Parkinson Disease
Interventions
DEVICE

Active NIR-PBM (MedX 1116, MCT502)

Near infrared light was delivered using two MedX Rehab Console systems (MedX Health, 1116). Each MedX console included a control unit and 3 superluminous light emitting diode (LED) clusters. Each LED cluster (3MedX MCT502) consisted of 52 near infrared diodes and 9 visible red diodes. The 9 red diodes were deactivated. The energy delivered by each cluster was 1 joule \[J\]/cm2 in 45 sec at treatment wavelength of 870 nm per each 20 min. The LED cluster has an irradiance of 22.2 mW/cm2, treats an area of 22.48 cm2, with an energy density of 26.64/cm2 per cluster (total energy of 599J/cluster). During each session, the 6 clusters were arrayed on the scalp in 2 configurations, 20 minutes per array. Each configuration targeted 6 transcranial sites, guided by the 10-20 system, for a total of 12 sites during the 40-min session. Total energy delivered was 599J/cluster X 12 sites = 7188J. Dosing was based on a pilot study. This intervention was given 3 times/week for 2 weeks.

DEVICE

Sham NIR-PBM (MedX 1116, MCT502)

The MedX sham intervention device is identical in all respects to the active device, except that the MedX console and diode clusters were modified to NOT deliver NIR light when turned on. The sham MedX devices were modified to deliver 'warmth', similar to that of the active devices. As with the active condition, a total of six sham interventions were given over a 2-week period, following the identical procedures described in the active condition.

Trial Locations (1)

32608

Norman Fixel Institute for Neurological Diseases, Gainesville

All Listed Sponsors
collaborator

Parkinson's Disease Foundation

OTHER

collaborator

The Parkinson's Institute

OTHER

lead

University of Florida

OTHER

NCT06688357 - Revitalize Cognition: Near Infrared Stimulation in Parkinson Patients | Biotech Hunter | Biotech Hunter