Pisa SyndromeNCT03737773
Prismatic Lenses in the Pisa Syndrome
A study testing glasses (prismatic lenses) and glasses (neutral) in people with Pisa Syndrome and Parkinson' Disease, run by Neuromed IRCCS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pisa Syndrome, Parkinson' Disease
- What is being tested?
- glasses (prismatic lenses) and glasses (neutral)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
Official title: Randomized Double-blind Study on the Effect of Orthoptic Rehabilitation in Pisa Syndrome Associated With Parkinson's Disease
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.
Read the detailed description
In previous cases of patients with Parkinson's disease and Pisa Syndrome, the investigators found a slight improvement in the dystonia of the trunk after the application of prismatic lenses.
The current study provides the involvement of 40 patients with Parkinson's disease, of which twenty treated with permanent prismatic optical correction, and twenty treated with neutral optical correction or with the only optical correction of the refractive basic defects (placebo).
The protocol provides the collection of these data:
- Personal data (date of birth, sex, marital status, profession)
- General history (weight, height, non-neurological and neurological concomitant pathologies, medical conditions that may be associated or predisposing patients to PS, non-antiparkinsonian therapy in progress)
- Specific history for PD (year from the first diagnosis of PD, year of appearance of the first motor symptoms of PD, type and distribution of motor symptoms at the onset)
- Pharmacological history of PD (year of initiation of the first treatment for PD, which drugs (s), antiparkinsonian therapy in progress)
- Neurological Evaluation in ON: UPDRS I, II, III and IV (III: also items-20-26 right and left side), Hoehn-Yahr stage;
- Specific history for PS;
- Detection of some information about the patients' perception of having the torso tilted sideways, direction of inclination, how long it is present, how long it is manifested, conditions in which this inclination is present (standing, sitting, etc.) )
- Presence of low back pain and pain intensity measured with the Visual Analogue Scale (VAS).
Clinical and kinematic evaluation of PS:
- The amount of dystonia measured in degrees with the patient positioned against the wall against a dedicated protractor. This measurement is photographed.
- Static and dynamic kinematic evaluation (gait analysis) 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.
Orthoptic evaluation:
complete orthoptic evaluation and prescription of personalized prismatic lenses, randomizing the patient on active or slow-moving placebo lenses with respect to the other experimenters and the patient.
Flowchart of visits:
Screening: the neurologist selects the patient according to the eligibility criteria indicated above and verifies the patient's willingness to participate.
Randomization: the patient undergoes clinical and kinematics evaluation of the PS, orthoptic examination and randomization on active lenses and placebo.
Study times:
T0: randomization and prescription of lenses T1: check after 1 month from the use of lenses
Patients are recruited at the Parkinson's Center of the IRCCS Neuromed.
- Conditions
- Pisa Syndrome, Parkinson' Disease
- Being tested
- glasses (prismatic lenses), glasses (neutral)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glasses (prismatic lenses)Other
glasses (neutral)Other
| Study group | Role | What they receive |
|---|---|---|
| group prisms | Active comparator | Patients that receive active prismatic lenses Receives: Other: glasses (prismatic lenses) |
| group placebo lenses | Placebo comparator | Patients that receive non-active prismatic lenses Receives: Other: glasses (neutral) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study startJul 2016
- Primary completionJul 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pisa SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Modugno, Neuromed IRCCS
- Investigators
- Nicola Modugno, MD, PHD, Principal investigator, Neuromed IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737773
- Sponsor's protocol ID
- PDNM-01
- Status last verified
- Nov 2018
- First submitted
- 30 Oct 2018
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Study on the Effect of Orthoptic Rehabilitation in Pisa Syndrome Associated With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03737773
- Acronym / sponsor ID
- PDNM-01
- Conditions
- Pisa Syndrome, Parkinson' Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In previous cases of patients with Parkinson's disease and Pisa Syndrome, the investigators found a slight improvement in the dystonia of the trunk after the application of prismatic lenses.
The current study provides the involvement of 40 patients with Parkinson's disease, of which twenty treated with permanent prismatic optical correction, and twenty treated with neutral optical correction or with the only optical correction of the refractive basic defects (placebo).
The protocol provides the collection of these data:
- Personal data (date of birth, sex, marital status, profession)
- General history (weight, height, non-neurological and neurological concomitant pathologies, medical conditions that may be associated or predisposing patients to PS, non-antiparkinsonian therapy in progress)
- Specific history for PD (year from the first diagnosis of PD, year of appearance of the first motor symptoms of PD, type and distribution of motor symptoms at the onset)
- Pharmacological history of PD (year of initiation of the first treatment for PD, which drugs (s), antiparkinsonian therapy in progress)
- Neurological Evaluation in ON: UPDRS I, II, III and IV (III: also items-20-26 right and left side), Hoehn-Yahr stage;
- Specific history for PS;
- Detection of some information about the patients' perception of having the torso tilted sideways, direction of inclination, how long it is present, how long it is manifested, conditions in which this inclination is present (standing, sitting, etc.) )
- Presence of low back pain and pain intensity measured with the Visual Analogue Scale (VAS).
Clinical and kinematic evaluation of PS:
- The amount of dystonia measured in degrees with the patient positioned against the wall against a dedicated protractor. This measurement is photographed.
- Static and dynamic kinematic evaluation (gait analysis) 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.
Orthoptic evaluation:
complete orthoptic evaluation and prescription of personalized prismatic lenses, randomizing the patient on active or slow-moving placebo lenses with respect to the other experimenters and the patient.
Flowchart of visits:
Screening: the neurologist selects the patient according to the eligibility criteria indicated above and verifies the patient's willingness to participate.
Randomization: the patient undergoes clinical and kinematics evaluation of the PS, orthoptic examination and randomization on active lenses and placebo.
Study times:
T0: randomization and prescription of lenses T1: check after 1 month from the use of lenses
Patients are recruited at the Parkinson's Center of the IRCCS Neuromed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group prisms | Active comparator | Other: glasses (prismatic lenses)Patients that receive active prismatic lenses |
| group placebo lenses | Placebo comparator | Other: glasses (neutral)Patients that receive non-active prismatic lenses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glasses (prismatic lenses) | Other | group prisms |
| glasses (neutral) | Other | group placebo lenses |
Primary outcome
Determine the change of dystonia in Pisa syndrome with the use of prisms
Time frame: 1 month
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.
Determine the kinematic variation in Pisa Syndrome with the use of prisms
Time frame: 1 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Pisa Syndrome
Recruiting
Integrating AI in Postural Rehabilitation for Parkinson's Disease
Parkinson Disease, Physical Inactivity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Modugno, MD, PHD principal investigator
Neuromed IRCCS
Questions about this trial
What is this clinical trial studying?
A study testing glasses (prismatic lenses) and glasses (neutral) in people with Pisa Syndrome and Parkinson' Disease, run by Neuromed IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the change of dystonia in Pisa syndrome with the use of prisms (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2018.