DRUG-FREE CLINICAL TRIALS
FOR DEMENTIA & PARKINSON'S DISEASE
Trial #1: Assessing Feasibility of Prolonged Repetitive Near Infrared Light Stimulation
in Early to Mid-Stage Dementia
in Early to Mid-Stage Dementia
Description: Individuals age 50-85 years experiencing memory problems and who have been independently diagnosed with early to mid-stage dementia are being recruited to participate in this trial. The study uses low-level light stimulation directed to the head. The stimulation sessions are conducted at home, twice daily, for 5 minutes over 60 consecutive days.
Safety studies conducted at Texas A&M University's Dept. of Neurosurgery have determined this treatment to have no negative side effects. The trial is randomized, placebo controlled and double blind, which means neither the researchers nor the trial participants will know what type of device they're receiving until after they complete the trial.
Requirements: Subject to eligibility criteria.
Services Cost: All study related services are provided at no cost to participants.
Compensation: Subjects completing 3, two-hour site assessments will be paid $75 for each completed site visit or a total of $225.
Note: Clinical trial participants are not required to stop or modify any of their current medications or other treatments.
Duration: 60 days
Informed Consent available at ClinicalTrials.gov: clinicaltrials.gov/ct2/show/NCT03750409?term=Baylor+Scott+White&cond=Dementia&rank=1 .
Safety studies conducted at Texas A&M University's Dept. of Neurosurgery have determined this treatment to have no negative side effects. The trial is randomized, placebo controlled and double blind, which means neither the researchers nor the trial participants will know what type of device they're receiving until after they complete the trial.
Requirements: Subject to eligibility criteria.
Services Cost: All study related services are provided at no cost to participants.
Compensation: Subjects completing 3, two-hour site assessments will be paid $75 for each completed site visit or a total of $225.
Note: Clinical trial participants are not required to stop or modify any of their current medications or other treatments.
Duration: 60 days
Informed Consent available at ClinicalTrials.gov: clinicaltrials.gov/ct2/show/NCT03750409?term=Baylor+Scott+White&cond=Dementia&rank=1 .
Trial #2: Efficacy of transcranial and intraocular infrared light stimulation on cognitive functioning in people with age related memory impairment (ARMI).
Description: Subjects’ brain electrical activity, memory and other cognitive abilities are tested before and after the 60-day trial period. Placebo group subjects will receive the active treatment after completion of the initial protocol. Treatment involves twice daily, 5-minute stimulation session using transcranial and intraocular infrared light helmet.
Requirements: Subject to availability and approval. All services are provided free of charge.
Services Cost: Provided at no cost upon approval.
Duration: 60 days
Consent Form: armi_informed_consent_51817.docx
Requirements: Subject to availability and approval. All services are provided free of charge.
Services Cost: Provided at no cost upon approval.
Duration: 60 days
Consent Form: armi_informed_consent_51817.docx
Trial #3: Effects of transcranial and intraocular infrared light stimulation on movement and gait in Parkinson's Disease.
Description: Brain electrical activity, arm movement and gait testing are carried out before and after the study period. The 60-day protocol involves twice daily, 5-minute training sessions that are conducted at home to allow subjects to participate even if they are living at a distance. For a description of the protocol and scientific research behind the use of this technology click here www.cerebrolite.com/p7.htm
Requirements: Subjects must have a diagnosis of Parkinson's disease to be eligible. All services are provided free of charge.
Services Cost: Provided at no cost upon approval.
Duration: 60 Days
Consent Form: informed_consent_pd2017.docx
Requirements: Subjects must have a diagnosis of Parkinson's disease to be eligible. All services are provided free of charge.
Services Cost: Provided at no cost upon approval.
Duration: 60 Days
Consent Form: informed_consent_pd2017.docx
| flyer_pd2.docx |
Trial #4: Effects of Vielight 810nm transcranial and intranasal light stimulation on EEG activation.
Description: This is an uncontrolled open label clinical trial which means that the subject is aware they are getting an active treatment and there is no control group as in the previously described studies. The goal is to assess quantitative EEG response to this type of stimulation across a range of clinical subpopulations and settings. Subject will pay an equipment fee of $1400 that represents a 20% discount of $350 from the study device's cost. (Vielight Neuro Alpha 10Hz or Gamma 40Hz). The discount is provided in consideration of subject's participation and agreeing to have two recordings of the brain activity conducted; one prior to beginning use of the device and the latter after two months of regular treatment. There is a 6-month, 80% refund policy in place on these devices if returned in resalable condition. The choice of Alpha (10Hz) or Gamma (40Hz) unit will be based on the subject's diagnosis and therapeutic goals, e.g., Alpha for pain relief and depressive symptoms and the Gamma for neurocognitive deficits. Quantitative EEG recordings will be conducted immediately prior to initiating stimulation sessions and after two months of consistent usage.
Requirements: All treatment services are provided free of charge while you will need to purchase EEG Response gear.
Services Cost: $1400 which includes a 20% discount of $350 from the study device's price; treatment sessions are self administered.
Duration: 60 days
Consent Form: contact Dr. Berman for informed consent document
Descriptive Paper on Photobiomodulation and Dementia:
Requirements: All treatment services are provided free of charge while you will need to purchase EEG Response gear.
Services Cost: $1400 which includes a 20% discount of $350 from the study device's price; treatment sessions are self administered.
Duration: 60 days
Consent Form: contact Dr. Berman for informed consent document
Descriptive Paper on Photobiomodulation and Dementia:
| lew_lim_vielight_paper_biosciences_and_medicines_2018.pdf |
Trial #5: Long-term effect of transcranial and intraocular 1068nm photobiomodulation and QEEG-driven neurofeedback training on cognitive and behavioral symptoms of neurodegenerative disorders
Description: This is a single subject, long-term clinical trial involving the combined use of 1060-1080nm transcranial and intraocular infrared light stimulation coupled with QEEG-based neurofeedback training to determine the longer term impact on neurodegenerative disorders, e.g., dementia, Parkinson's disease, ALS, traumatic brain injury, etc. Subjects pay a $15,000 equipment fee for use of study related equipment in their home over the study period. This fee is due at the study's initiation with partial refund available with early termination. No additional equipment fees will be charged after the initial study period and once FDA approval has been obtained for the appropriate indication, subjects may then purchase the study devices for $1.00.
Quantitative EEG recordings will be conducted quarterly along with online neuropsychological testing and clinical interviews. Subjects will conduct all treatment sessions themselves after being provided with training and supervision by trial staff members. Compliance will be monitored by photographic and video monitoring via internet telecommunications application, e.g., SKYPE, FaceTime or ZOOM.
Requirements: All treatment services are provided free of charge while you will need to purchase EEG Response gear.
Equipment Fee: $15,000 which includes both Cognitolite and 2-channel neurofeedback amplifier, electrodes and software installation and training. All treatment, supervision and evaluation services are provided at no cost.
Duration: 2 years
Informed Consent Form:
Quantitative EEG recordings will be conducted quarterly along with online neuropsychological testing and clinical interviews. Subjects will conduct all treatment sessions themselves after being provided with training and supervision by trial staff members. Compliance will be monitored by photographic and video monitoring via internet telecommunications application, e.g., SKYPE, FaceTime or ZOOM.
Requirements: All treatment services are provided free of charge while you will need to purchase EEG Response gear.
Equipment Fee: $15,000 which includes both Cognitolite and 2-channel neurofeedback amplifier, electrodes and software installation and training. All treatment, supervision and evaluation services are provided at no cost.
Duration: 2 years
Informed Consent Form:
| mid_ssic_nfb_for_dementia.docx |