A Study Using Transorbital Alternating Current Stimulation for People With Glaucoma

February 7, 2024 updated by: NYU Langone Health

A Multi-site Interventional Pilot Study Using Transorbital Alternating Current Stimulation for People With Glaucoma

This pilot study will test the preliminary efficacy and feasibility of an intervention protocol for one method of electric current stimulation, repetitive transorbital alternating current stimulation (rtACS), to treat visual impairment in people with glaucoma. We will evaluate a study protocol to use in future clinical trials to test the effectiveness of rtACS to ameliorate the progressive effects of vision loss both structurally and functionally in the eye, the visual pathway, and in regard to people's independence (i.e., functional ability). In this prospective, randomized controlled, double-masked pilot study, we will: 1) determine an effect of rtACS on ophthalmic structure and function (from retina to visual brain), 2) assess the methodology of procedures for assessment of people's functional ability and quality of life (QoL) to determine an effect of rtACS, and 3) assess the feasibility and implementation of the pilot study protocol for a larger multi-site, randomized controlled trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants will engage in baseline, intervention, post-intervention, and follow-up visits over the span of approximately 8 weeks. The expected outcomes for this project are that (1) rtACS activates viable but poorly or non-functional retinal ganglion cells to improve their structural and functional capabilities, (2) measures of retinal, optic nerve, and visual brain structures and function will correspond with improvement in visual function, and (3) changes in visual function following rtACS will be associated with improvements in participants' functional ability and QoL. rtACS has successfully been used in the rehabilitation of visual impairments in people with optic neuropathies; however, we do not know the clinical value of rtACS specifically for people with glaucoma, including the effect of rtACS on people's functional ability and QoL.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Live in a community, residential setting (i.e., non-institutionalized, not homeless)
  • Diagnosis of glaucoma (not type-specific, excluding traumatic glaucoma): Moderate defect or worse in both eyes but not total blindness
  • Visual field defects present for at least 6 months
  • Best-corrected visual acuity of 20/200 (1.0 logMAR) or better in at least one eye
  • Commitment to comply with study procedures (2 week period of intervention sessions) with baseline, post-intervention, and follow-up visits

Exclusion Criteria:

  • Other optic comorbidity than glaucoma
  • End-stage organ disease or medical condition with subsequent vision loss (e.g., diabetes, stroke)
  • Other diseases of the retina or cataracts responsible for worse than 20/70 best-corrected visual acuity
  • Photosensitivity to flickering lights

  • Intraocular Pressure (IOP) > 27 mmHg at baseline

    * Medically diagnosed memory disorder or Telephone Interview for Cognitive Status-modified (TICS-m) score ≤ 27

  • Electric or electronic implants (e.g., cardiac pacemaker)
  • Metallic artifacts/implants in head and/or torso
  • Diagnosed epilepsy
  • Epileptic seizure within the past 3 years of enrollment date
  • Auto-immune disease, acute stage (e.g., rheumatoid arthritis)
  • Metastatic disease
  • Certain mental diseases/psychiatric conditions (e.g., schizophrenia) that would preclude reliable testing and participation
  • Unstable medical conditions (e.g., diabetes, diabetes causing diabetic retinopathy)
  • Claustrophobia (to limit functional neuroimaging)
  • Received rtACS in the past

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: rtACS Stimulation Group
Device: rtACS Stimulation
Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
Sham Comparator: Sham Intervention Group
Sham stimulation looks like rtACS, but is not active rtACS.
Device: Sham Intervention
A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Peripapillary RNFL Thickness
Time Frame: Baseline, Week 4
Peripapillary retinal nerve fiber layer (RNFL) thickness (μm) measured using optical coherence tomography (OCT).
Baseline, Week 4
Change in Macular Ganglion Cell-Inner Plexiform Layer Thickness
Time Frame: Baseline, Week 4
Macular ganglion cell-inner plexiform layer thickness (μm) measured using OCT.
Baseline, Week 4
Change in Humphrey Visual Field Analyzer Score
Time Frame: Baseline, Week 4
The Humphrey Visual Field Analyzer assesses the mean deviation (dB), a measure of visual field sensitivity through threshold testing. dBs tested by the Humphrey analyzer range between 0 and 50 dB (0 is the brightest and 50 is the dimmest). A value of 0 means the patient could not see the brightest target, and a 50 means the dimmest target was seen. Most values are around 30 dB, and any numbers below this range imply a possible visual field defect.
Baseline, Week 4
Change in Minnesota Low Vision Reading Test (MNRead): Reading Acuity Score
Time Frame: Baseline, Week 4
An estimate of reading acuity is given by the smallest print size at which the patient can read the entire sentence without making significant errors. This method measures acuity to the nearest 0.1 logMAR. Each sentence in the MNRead Reading Acuity chart has 60 characters, which corresponds to 10 standard length words, assuming a standard word length of 6 characters (including a space). Reading acuity is calculated as follows: Reading acuity = size of smallest sentence read + 0.01 x number of errors.
Baseline, Week 4
Change in Score on National Eye Institute Visual Functioning Questionnaire (VFQ-39)
Time Frame: Baseline, Week 4
National Eye Institute VFQ-39 measures health-related quality of life in 12 domains: general vision, ocular pain, near activities, distance activities, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision, peripheral vision, and composite score. For each domain: the lowest and highest possible scores are 0 and 100 points, respectively. Higher score means higher functioning. The total score is the average of the domain scores.
Baseline, Week 4
Change in Score on 36-Item Short Form Survey (SF-36)
Time Frame: Baseline, Week 4
The SF-36 is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state. The total score is the average of the domain scores.
Baseline, Week 4
Percentage Change in ON Head Cup-to-Disc Ratio
Time Frame: Baseline, Week 4
Percentage change in optic nerve (ON) head cup-to-disc ratio measured using OCT.
Baseline, Week 4
Change in Score on Assessment of Life Habits (LIFE-H), Short Form 3.1
Time Frame: Baseline, Week 4
The LIFE-H short form 3.1 is a 77-item questionnaire developed to measure: (1) how a respondent accomplishes regular activities and social roles and (2) respondent's satisfaction with how regular activities and social roles are accomplished. The LIFE-H total score is obtained by summing the scores on each item and then dividing by the number of items. The LIFE-H score ranges from 0 to 9, where a score of 0 indicates total handicap or total disruption in participation and a score of 9 means an optimal level of participation.
Baseline, Week 4
VEP-Measured Amplitude (15% Contrast) at Baseline
Time Frame: Baseline
Visual evoked potential (VEP) identifies decreased visual function and helps with discriminations of glaucomatous changes by measuring amplitude (micro volts) and latency (milliseconds (ms)) with 15% contrast parameters.
Baseline
VEP-Measured Latency (15% Contrast) at Baseline
Time Frame: Baseline
Visual evoked potential (VEP) identifies decreased visual function and helps with discriminations of glaucomatous changes by measuring amplitude (micro volts) and latency (milliseconds (ms)) with 15% contrast parameters.
Baseline
VEP-Measured Amplitude (85% Contrast) at Baseline
Time Frame: Baseline
Visual evoked potential (VEP) identifies decreased visual function and helps with discriminations of glaucomatous changes by measuring amplitude (micro volts) and latency (milliseconds (ms)) with 85% contrast parameters.
Baseline
VEP-Measured Latency (85% Contrast) at Baseline
Time Frame: Baseline
Visual evoked potential (VEP) identifies decreased visual function and helps with discriminations of glaucomatous changes by measuring amplitude (micro volts) and latency (milliseconds (ms)) with 85% contrast parameters.
Baseline
VEP-Measured Amplitude (15% Contrast) at Week 4
Time Frame: Week 4
Visual evoked potential (VEP) identifies decreased visual function and helps with discriminations of glaucomatous changes by measuring amplitude (micro volts) and latency (milliseconds (ms)) with 15% contrast parameters.
Week 4
VEP-Measured Latency (15% Contrast) at Week 4
Time Frame: Week 4
Visual evoked potential (VEP) identifies decreased visual function and helps with discriminations of glaucomatous changes by measuring amplitude (micro volts) and latency (milliseconds (ms)) with 15% contrast parameters.
Week 4
VEP-Measured Amplitude (85% Contrast) at Week 4
Time Frame: Week 4
Visual evoked potential (VEP) identifies decreased visual function and helps with discriminations of glaucomatous changes by measuring amplitude (micro volts) and latency (milliseconds (ms)) with 85% contrast parameters.
Week 4
VEP-Measured Latency (85% Contrast) at Week 4
Time Frame: Week 4
Visual evoked potential (VEP) identifies decreased visual function and helps with discriminations of glaucomatous changes by measuring amplitude (micro volts) and latency (milliseconds (ms)) with 85% contrast parameters.
Week 4
Pelli-Robson Contrast Sensitivity Chart Score at Baseline
Time Frame: Baseline
The Pelli-Robson test measures contrast sensitivity using a single large letter size (20/60 optotype), with contrast varying across groups of letters. The chart uses letters (6 per line), arranged in groups whose contrast varies from high to low. Patients read the letters, starting with the highest contrast, until they are unable to read two or three letters in a single group. A score is assigned based on the contrast of the last group in which two or three letters were correctly read. The score, a single number, is a measure of the subject's log contrast sensitivity. A Pelli-Robson score of 2.0 indicates normal contrast sensitivity of 100 percent. Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents in visual disability.
Baseline
Pelli-Robson Contrast Sensitivity Chart Score at Week 4
Time Frame: Week 4
The Pelli-Robson test measures contrast sensitivity using a single large letter size (20/60 optotype), with contrast varying across groups of letters. The chart uses letters (6 per line), arranged in groups whose contrast varies from high to low. Patients read the letters, starting with the highest contrast, until they are unable to read two or three letters in a single group. A score is assigned based on the contrast of the last group in which two or three letters were correctly read. The score, a single number, is a measure of the subject's log contrast sensitivity. A Pelli-Robson score of 2.0 indicates normal contrast sensitivity of 100 percent. Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents in visual disability.
Week 4
Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Score (VAS) at Baseline
Time Frame: Baseline
ETDRS charts have five Sloan letters on each line; the lines are of equal difficulty, and there is a geometric progression in letter size from line to line. Beginning with Chart 1, the right eye is tested with the left eye occluded. Following the completion of testing the right eye, the left eye is tested with Chart 2 while covering the right eye. Each letter is scored as right or wrong. Correct letters are circled on the scoresheet. Each letter read correctly is assigned a score and each line is totaled at the end of testing. VAS awards one point for every letter correctly guessed. The total scores range from 0 to 100, with higher scores indicating greater visual acuity.
Baseline
Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Score (VAS) at Week 4
Time Frame: Week 4
ETDRS charts have five Sloan letters on each line; the lines are of equal difficulty, and there is a geometric progression in letter size from line to line. Beginning with Chart 1, the right eye is tested with the left eye occluded. Following the completion of testing the right eye, the left eye is tested with Chart 2 while covering the right eye. Each letter is scored as right or wrong. Correct letters are circled on the scoresheet. Each letter read correctly is assigned a score and each line is totaled at the end of testing. VAS awards one point for every letter correctly guessed. The total scores range from 0 to 100, with higher scores indicating greater visual acuity.
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joel Schuman, MD, FACS, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 14, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-02005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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