Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT03330353

Conditions

PSP - Progressive Supranuclear Palsy

PD - Parkinson's Disease

AD - Alzheimer's Disease

ALS (Amyotrophic Lateral Sclerosis)

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Pupillometry

Study Details

Brief summary:

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.

Conditions

PSP - Progressive Supranuclear Palsy

PD - Parkinson's Disease

AD - Alzheimer's Disease

ALS (Amyotrophic Lateral Sclerosis)

Study ID

NCT03330353

Start date

Nov 1, 2017

Status verified date

Nov, 2017

Completion date

Oct 1, 2019

Anticipated

Primary completion date

Oct 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

56 participants

Anticipated

Interventions and Outcome Measures

Arms

Neurodegenerative Diseases

Individuals with neurodegenerative diseases

Interventions

Pupillometry

Use of pupillometry to assess melanopsin-light pathway in patients with neurodegenerative diseases

Primary outcome measure

  • Maximal Pupil Constriction [ Time Frame: 2 years ]
  • Post-illumination pupil response (PIPR) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Shirley H Wray, MD, PhD

617-726-5539wray@helix.mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Shirley H Wray, MD, PhD, FRCP

617-726-5539wray@helix.mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 7, 2017

Last verified

Nov, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2017-11-07.