RECRUITING

Electrical Stimulation for the Treatment of Optic Neuropathies

Conditions

Glaucoma Glaucoma, Open-Angle Optic Nerve Diseases

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-02-27

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05626426

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Participant must be at least 18. 2. Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE). 3. 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%. 4. In the opinion of the investigator the participant's eye pressure must be clinically stable. 5. 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. 6. 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.	1. Participant is unable to comply with study procedures or follow-up visits. 2. Participant has a history of ocular herpes zoster. 3. Participant has pathological nystagmus 4. Participant has evidence of visually significant retinopathy including but not limited to Diabetic retinopathy or retinitis pigmentosa. 5. Participant has evidence of corneal opacification or lack of optical clarity. 6. Participant has uveitis or other ocular inflammatory disease. 7. Participant has any electric or electroinc implants such as a pacemaker. 8. Participant has acute conjunctivitis. 9. Participant has acute autoimmune disease. 10. Participant is pregnant or lactating. 11. 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. 12. Unresected brain tumors 13. 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 14. Patients with any skin damage. 15. Children and comatose patients. 16. Patients with history of epileptic seizure within the last 10 years. 17. Patients with uncontrolled systemic hypertension or uncontrolled diabetes. 18. 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 19. Prior participation in a vision training/stimulation study in the last 12 months

Inclusion Criteria

Exclusion Criteria

1. Participant must be at least 18.
2. Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE).
3. 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%.
4. In the opinion of the investigator the participant's eye pressure must be clinically stable.
5. 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.
6. 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.

1. Participant is unable to comply with study procedures or follow-up visits.
2. Participant has a history of ocular herpes zoster.
3. Participant has pathological nystagmus
4. Participant has evidence of visually significant retinopathy including but not limited to Diabetic retinopathy or retinitis pigmentosa.
5. Participant has evidence of corneal opacification or lack of optical clarity.
6. Participant has uveitis or other ocular inflammatory disease.
7. Participant has any electric or electroinc implants such as a pacemaker.
8. Participant has acute conjunctivitis.
9. Participant has acute autoimmune disease.
10. Participant is pregnant or lactating.
11. 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.
12. Unresected brain tumors
13. 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
14. Patients with any skin damage.
15. Children and comatose patients.
16. Patients with history of epileptic seizure within the last 10 years.
17. Patients with uncontrolled systemic hypertension or uncontrolled diabetes.
18. 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
19. Prior participation in a vision training/stimulation study in the last 12 months

Contacts and Locations

Principal Investigator

Jeffrey L Goldberg, MD PhD

PRINCIPAL_INVESTIGATOR

Stanford University

Study Locations (Sites)

Byers Eye Institute

Palo Alto, California, 94303

United States

Collaborators and Investigators

Sponsor: Stanford University

Jeffrey L Goldberg, MD PhD, PRINCIPAL_INVESTIGATOR, Stanford University

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 Registration Dates

Study Start Date2023-02-27

Study Completion Date2025-12

Study Record Updates

Study Start Date2023-02-27

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Glaucoma
Glaucoma, Open-Angle
Optic Nerve Diseases