Prismatic Lenses in the Pisa Syndrome

NCT03737773 | Completed

• 1 other identifier: PDNM-01
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Non-pharmacological interventional pilot study on the effect of prismatic glasses for the improvement of Pisa syndrome in Parkinson's disease. The study involves 40 patients, of whom 20 receive active treatment and 20 slow placebo. At the end of the study, all patients receive corrective lenses in compassionate use if the study yields positive results.

Conditions

Pisa Syndrome; Parkinson' Disease

Outcome Measures

Primary Outcomes (2)

• Determine the change of dystonia in Pisa syndrome with the use of prisms

  Verify the possible variation of dystonia in patients affected by Pisa Syndrome after the use for a month of prismatic lenses prescribed during the randomization phase with the aid of a wall protractor through the recording of the amount of dystonia measured in degrees with the patient positioned against the wall against a dedicated protractor. This measurement is photographed.

  1 month

• Determine the kinematic variation in Pisa Syndrome with the use of prisms

  Verify the static and dynamic kinematic variation in patients affected by Pisa Syndrome after the use for a month of prismatic lenses prescribed during the randomization phase and according to the following protocol: 30 seconds stationary in orthostatic position, shoulders to the cameras, about 5 steps forward, stationary in orthostatic position while fixing visual stimulation points placed on the wall, 30 second stationary in an orthostatic position after having covered a section of the corridor in front of the kinematic evaluation room.

  1 month

Study Arms (2)

group prisms

ACTIVE COMPARATOR

Patients that receive active prismatic lenses

Other: glasses (prismatic lenses)

group placebo lenses

PLACEBO COMPARATOR

Patients that receive non-active prismatic lenses

Other: glasses (neutral)

Interventions

glasses (prismatic lenses) OTHER

group prisms

glasses (neutral) OTHER

group placebo lenses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥ 18 years
• Diagnosis of PD according to the diagnostic criteria of the United Kingdom Brain Bank with or without dementia (but with MMSE\> 14)
• Hoehn-Yahr Stadium from 1 to 4
• Signature of Informed Consent and the privacy form

You may not qualify if:

• Patients with morphostructural changes in the spine that exclude the diagnosis of PS.
• Patients with symptoms and signs compatible with atypical parkinsonism
• Patients affecd by PD treated with antagonist drugs for central dopaminergic receptors (first generation antipsychotics and second generation with the exception of clozapine and quetiapine, antiemetic, prokinetic, etc.) in the last 6 months before enrollment
• Patients with a history of major spinal surgery (tumors, infections, ankylosing spondylitis, paraneoplastic syndromes)
• Other neurological diseases.
• Patients with manifested disorders of eeye movement disorders prior to the diagnosis of PD
• Patents with abnormalities of normal binocular vision
• Patients with amblyopia, medium or high anisometropy,
• Patients with a binocular vision acuity less than 7/10
• Patients with evolved cataracts
• Pateints with glaucoma
• Patients with active maculopathies
• Patients with severe mono or binocular visual field depressions of different origins Patients with astigmatisms higher than 3 dioptres, hypermetropias or myopias greater than 3 dioptres

Sponsors & Collaborators

• Neuromed IRCCS: lead

MeSH Terms

Conditions

Parkinson Disease

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Nicola Modugno, MD, PHD

  Neuromed IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist, Head of Parkinson Center

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 13, 2018
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 13, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share