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Electrical Stimulation for the Treatment of Optic Neuropathies (rtACS)

Primary Purpose

Glaucoma, Glaucoma, Open-Angle, Optic Nerve Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repetitive, Transorbital Alternating Current Stimulation (rtACS)
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participant must be at least 18. Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE). Participant's clinical diagnosis must be consistent with glaucoma characterized by the following features: Mean deviation (MD) worse than -3 on Humphrey Visual Field 24-2 testing. Reliable visual field measures, fixation losses do not exceed 20% and false postivies do not exeed 20%. In the opinion of the investigator the participant's eye pressure must be clinically stable. If a participant has two eyes meeting study criteria, the worse eye as determined by mean deviation. If both eyes qualify and have the same MD, the patient may choose which eye they are willing to enter, or else a randomization procedure will assign one eye to the study. Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety. Exclusion Criteria: Participant is unable to comply with study procedures or follow-up visits. Participant has a history of ocular herpes zoster. Participant has pathological nystagmus Participant has evidence of visually significant retinopathy including but not limited to Diabetic retinopathy or retinitis pigmentosa. Participant has evidence of corneal opacification or lack of optical clarity. Participant has uveitis or other ocular inflammatory disease. Participant has any electric or electroinc implants such as a pacemaker. Participant has acute conjunctivitis. Participant has acute autoimmune disease. Participant is pregnant or lactating. Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments. Including but not limited to all forms of dementia. Unresected brain tumors Implanted intracranial magnetic metals (metallic implants in the head / skull such as clamps, coils, ventriculo-peritoneal shunts, endoprostheses, etc.), which are not MRI-compatible. Note: metallic dental implants and titanium screws or plates are acceptable Patients with any skin damage. Children and comatose patients. Patients with history of epileptic seizure within the last 10 years. Patients with uncontrolled systemic hypertension or uncontrolled diabetes. Participant is not able to travel, to comply with the requirements of the study or not willing to complete the schedule of events (SOE) and/or unable to confirm follow-up participation Prior participation in a vision training/stimulation study in the last 12 months

Sites / Locations

  • Byers Eye InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active SASm

Arm Description

Patients will receive active treatment with the device every other day over 8 weeks.

Outcomes

Primary Outcome Measures

Change from baseline in visual field assessed by Humphrey Visual Field Index (VFI).
Change from baseline in visual field assessed by Humphrey Mean Deviation (MD).

Secondary Outcome Measures

Change from baseline in ganglion cell layer as measured by optical coherence tomography (OCT, visible light and/or infrared).
Change from baseline in nerve fiber layer thickness as measured by optical coherence tomography (OCT, visible light and/or infrared).
Change from baseline in visual acuity as assessed by the Snellen visual acuity test.
The Snellen test is a standard eye chart test used to test eyesight.
Change from baseline in visual evoked potential.
Change from baseline in retinal metabolic analysis(RMA)/OcuMet imaging.
There are two index measures of retinal metabolism and a normative database; change from baseline with a statistically significant difference from test-retest variability will be the exploratory endpoint measured here.
Change from baseline in adaptive optics retinal imaging.
There are no index measures for adaptive optics retinal imaging in this disease; change from baseline will be the exploratory endpoint measured here.
Change from baseline in laser speckle flowgraphy
There is one index measure of retinal blood flow response to light stimulation; change from baseline with a statistically significant difference from test-retest variability will be the exploratory endpoint measured here.
Change from baseline in OCT angiography
There are 3 index measures of retinal blood flow in OCT-A; change from baseline with a statistically significant difference from test-retest variability will be the exploratory endpoint measured here.

Full Information

First Posted
November 15, 2022
Last Updated
March 6, 2023
Sponsor
Stanford University
Collaborators
NYU Langone Health, Otto-von-Guericke University Magdeburg
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1. Study Identification

Unique Protocol Identification Number
NCT05626426
Brief Title
Electrical Stimulation for the Treatment of Optic Neuropathies
Acronym
rtACS
Official Title
An Open-Label Study to Evaluate the Safety and Efficacy of Repetitive, Transorbital Alternating Current Stimulation (rtACS) for the Treatment of Optic Neuropathies
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
NYU Langone Health, Otto-von-Guericke University Magdeburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall aim of this study is to see whether long-term electrical stimulation with a home-stimulation device works well and is safe for the treatment of open-angle glaucoma. Open-Angle Glaucoma is a disease where the nerves in the back of your eye die off faster than expected regardless of your eye pressure.
Detailed Description
This is a concurrent open-label study for patients who are deemed safe to participate in the electrical stimulation trial but do not fit the exact criteria for the randomized clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Glaucoma, Open-Angle, Optic Nerve Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active SASm
Arm Type
Experimental
Arm Description
Patients will receive active treatment with the device every other day over 8 weeks.
Intervention Type
Device
Intervention Name(s)
Repetitive, Transorbital Alternating Current Stimulation (rtACS)
Other Intervention Name(s)
Electrical Stimulation
Intervention Description
Patients receive treatment every other day via a headband that delivers electrical stimulation to the retina
Primary Outcome Measure Information:
Title
Change from baseline in visual field assessed by Humphrey Visual Field Index (VFI).
Time Frame
Baseline through 6 months
Title
Change from baseline in visual field assessed by Humphrey Mean Deviation (MD).
Time Frame
Baseline through 6 months
Secondary Outcome Measure Information:
Title
Change from baseline in ganglion cell layer as measured by optical coherence tomography (OCT, visible light and/or infrared).
Time Frame
Baseline through 6 months
Title
Change from baseline in nerve fiber layer thickness as measured by optical coherence tomography (OCT, visible light and/or infrared).
Time Frame
Baseline through 6 months
Title
Change from baseline in visual acuity as assessed by the Snellen visual acuity test.
Description
The Snellen test is a standard eye chart test used to test eyesight.
Time Frame
Baseline through Month 6
Title
Change from baseline in visual evoked potential.
Time Frame
Baseline through Month 6
Title
Change from baseline in retinal metabolic analysis(RMA)/OcuMet imaging.
Description
There are two index measures of retinal metabolism and a normative database; change from baseline with a statistically significant difference from test-retest variability will be the exploratory endpoint measured here.
Time Frame
Baseline through Month 6
Title
Change from baseline in adaptive optics retinal imaging.
Description
There are no index measures for adaptive optics retinal imaging in this disease; change from baseline will be the exploratory endpoint measured here.
Time Frame
Baseline through Month 6
Title
Change from baseline in laser speckle flowgraphy
Description
There is one index measure of retinal blood flow response to light stimulation; change from baseline with a statistically significant difference from test-retest variability will be the exploratory endpoint measured here.
Time Frame
Baseline through Month 6
Title
Change from baseline in OCT angiography
Description
There are 3 index measures of retinal blood flow in OCT-A; change from baseline with a statistically significant difference from test-retest variability will be the exploratory endpoint measured here.
Time Frame
Baseline through Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant must be at least 18. Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE). Participant's clinical diagnosis must be consistent with glaucoma characterized by the following features: Mean deviation (MD) worse than -3 on Humphrey Visual Field 24-2 testing. Reliable visual field measures, fixation losses do not exceed 20% and false postivies do not exeed 20%. In the opinion of the investigator the participant's eye pressure must be clinically stable. If a participant has two eyes meeting study criteria, the worse eye as determined by mean deviation. If both eyes qualify and have the same MD, the patient may choose which eye they are willing to enter, or else a randomization procedure will assign one eye to the study. Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety. Exclusion Criteria: Participant is unable to comply with study procedures or follow-up visits. Participant has a history of ocular herpes zoster. Participant has pathological nystagmus Participant has evidence of visually significant retinopathy including but not limited to Diabetic retinopathy or retinitis pigmentosa. Participant has evidence of corneal opacification or lack of optical clarity. Participant has uveitis or other ocular inflammatory disease. Participant has any electric or electroinc implants such as a pacemaker. Participant has acute conjunctivitis. Participant has acute autoimmune disease. Participant is pregnant or lactating. Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments. Including but not limited to all forms of dementia. Unresected brain tumors Implanted intracranial magnetic metals (metallic implants in the head / skull such as clamps, coils, ventriculo-peritoneal shunts, endoprostheses, etc.), which are not MRI-compatible. Note: metallic dental implants and titanium screws or plates are acceptable Patients with any skin damage. Children and comatose patients. Patients with history of epileptic seizure within the last 10 years. Patients with uncontrolled systemic hypertension or uncontrolled diabetes. Participant is not able to travel, to comply with the requirements of the study or not willing to complete the schedule of events (SOE) and/or unable to confirm follow-up participation Prior participation in a vision training/stimulation study in the last 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey L Goldberg, MD PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Byers Eye Institute
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zac Wennberg-Smith
Phone
650-497-5942
Email
zacwenn@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Electrical Stimulation for the Treatment of Optic Neuropathies

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