ALS (Amyotrophic Lateral Sclerosis) Clinical Trial
— PMPSPOfficial title:
Functional Assessment of the Melanopsin-Containing Retinal Ganglion Cells in Progressive Supranuclear Palsy Using Chromatic Pupillometry
The specific aim of this study is to investigate rod, cone and melanopsin driven pupillary
light response in individuals with progressive supranuclear palsy (PSP), age-matched healthy
controls and individuals with other neurodegenerative diseases using chromatic pupillometry,
with special interest in assessing melanopsin-driven post-illumination pupil response (PIPR)
as an identifier for PSP.
The study addresses the following hypotheses:
1. Chromatic pupil responses, including rod/cone-driven rapid phase constriction and
melanopsin-driven PIPR, are reduced in subjects with PSP compared to age-matched normal
healthy control subjects,
2. Pupil parameters of the melanopsin-driven PIPR are abnormal in PSP subjects without
supranuclear palsy, which is indicative of a subclinical physiological deficit of the
OPN in the early stages of PSP.
If these hypotheses are upheld, chromatic pupillometry to measure the PIPR promises to be a
reliable in vivo, non-invasive, convenient and inexpensive technique to detect asymptomatic
pupillomotor impairment in advance of diagnostic oculomotor signs and deterioration of
cognitive function.
Status | Recruiting |
Enrollment | 56 |
Est. completion date | October 1, 2019 |
Est. primary completion date | October 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years and older |
Eligibility |
Inclusion Criteria: 1. Individuals that meet the clinical criteria for PSP. Core features include: - Recurrent falls and unsteady gait - Axial and nuchal rigidity - Pseudobulbar palsy - Bilateral lid retraction - Supranuclear vertical gaze palsy - Atrophy of the midbrain tegmentum (the hummingbird sign on brain MRI, 2. Individuals that fit the criteria for the second PSP phenotype (which resembles PD) that has asymmetric findings, tremors and poor responses to treatment with Levodopa, 3. Individuals that meet the clinical criteria for PD with: - Progressive bradykinesia - Postural instability and frequent falls - Festinating gait with loss of associated movements - Cogwheel rigidity and mask-like face - Rest tremor, 4. Individuals who carry a diagnosis of Alzheimer' disease who present with progressive impairment of memory and cognitive domains such as language and visuospatial perception. Diagnoses will be confirmed by the review of health/medical records of patients recruited from the Frontotemporal Disorders Unit clinic. In the case of participants recruited from research studies, diagnoses will be confirmed by the review of the research diagnoses indicated on the individuals' research records. Exclusion Criteria: 1. Individuals who are frail or in questionable health, 2. Individuals with cataracts or with posterior pole ocular pathology such as age-related macular degeneration and optic neuropathies, including open angle high intraocular pressure glaucoma, 3. Individuals with photophobia (i.e., painful light sensitivity) when exposed to bright light, including those with ophthalmological conditions such as keratitis (herpes simplex), uveitis or Achromatopsia, 4. Individuals with advanced dementia with inability to sit erect, hold the eyes open, incontinence, 5. Individuals with epilepsy, 6. Individuals diagnosed with major depression or other severe psychiatric disorders |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | NeurOptics Inc., University of Toronto |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximal Pupil Constriction | The smallest pupil size following light stimulation. This parameter primarily represents rapid phase extrinsic ipRGC activity driven by rods and cones through synaptic input. | 2 years | |
Primary | Post-illumination pupil response (PIPR) | Measured pupil diameter over a period of 20 seconds, from 10 to 30 seconds after the offset of light stimulation. | 2 years |
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