BridgeMD
New treatment option for Optic Neuropathy
Official title Repetitive Transorbital Alternating Current Stimulation for Optic Neuropathies
ClinicalTrials.gov ID: NCT06662448
What this study is testing
- What it's testing
- The purpose of this study is to test the efficacy and feasibility of an intervention protocol for home-based repetitive transorbital alternating current stimulation (rtACS) for the treatment of visual impairment in people with optic neuropathy. The primary aims are to evaluate the effectiveness of home-based rtACS to ameliorate the progressive effects of vision loss functionally in the eye and the visual pathway, and in regard to people's independence (i.e., functional ability).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Age equal to or over 18 years old
- Must have a permanent residence
- Diagnosis of optic neuropathy
- VF defects present in at least one eye (MD ≤ -3.00 dB) FL, FP, FN \<33%
- Visual Field Index (VFI) 10-90%
You likely can't join if
- High intraocular pressure (over 27 mmHg)
- End-stage organ disease or medical condition with subsequent vision loss (e.g., diabetes, stroke)
- Advanced or unstable retinal diseases
- Pathological nystagmus
- Acute conjunctivitis
- Photosensitivity to flickering lights
See the full eligibility criteria
- Age equal to or over 18 years old
- Must have a permanent residence
- Diagnosis of optic neuropathy
- VF defects present in at least one eye (MD ≤ -3.00 dB) FL, FP, FN \<33%
- Visual Field Index (VFI) 10-90%
- Clear optical apparatus
- Best-corrected VA of 20/400 or better in at least one eye
- Commitment to comply with study procedures: 8-week period of intervention sessions (30 sessions every other day), baseline visit, post-intervention visit, and 2 follow-up visits (2 days per visit).
- Scheduling
- Testing
- A subject deemed incapable of performing the study intervention independently due to visual impairment or any other condition that may prevent them from performing the intervention accurately require a family member or...
- High intraocular pressure (over 27 mmHg)
- End-stage organ disease or medical condition with subsequent vision loss (e.g., diabetes, stroke)
- Advanced or unstable retinal diseases
- Pathological nystagmus
- Acute conjunctivitis
- Photosensitivity to flickering lights
- Non-ocular/ocular surgery within the previous 2 months to enrollment date
- Electric or electronic implants (e.g., cardiac pacemaker)
- Metallic artifacts/implants in head and/or torso (titanium screw and dental implants are allowed)
- Diagnosed epilepsy on medical treatment
- Auto-immune disease, acute stage (e.g., rheumatoid arthritis)
- Metastatic disease
- Certain mental diseases/psychiatric conditions (e.g., schizophrenia) that would affect the subject's ability to perform all necessary study tasks
- Any chronic unstable medical conditions (e.g., uncontrolled diabetes,) that may cause a subject to miss one or more of the interventions and visits
- Addiction (e.g., drug/alcohol dependence) that has not been in abstinent control for at least one year
- Uncontrolled systemic hypertension (historical BP \> 160/100 mmHg)
- Pregnant or breast-feeding women or women that are planning to become pregnant, as this device has not been tested on pregnant women and there is no data on using rtACS for this particular group
- Any severe skin condition (e.g., blisters, open wounds, cuts or irritation) or other skin defect which compromise the integrity of the skin at or near stimulation locations
- IOP that the principal investigator determines that is not clinically stable
- Complete blindness of both eyes
- Non-resected brain tumors
- Unstable diabetic retinopathy in the study eye
- Optic neuropathies secondary to brain tumors
- people without the capacity to consent
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.