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New treatment option for Retinitis Pigmentosa (RP)
Official title Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
ClinicalTrials.gov ID: NCT07341763
What this study is testing
- What it's testing
- The study aims to find out if non-invasive brain stimulation can enhance orientation and mobility skills in people with limited vision.
- Who it's for
- The study is looking for adults with conditions that cause vision impairment, such as retinitis pigmentosa or glaucoma.
- What's involved
- Participants will undergo three visits: one to check eligibility and two for brain stimulation, one active and one placebo. Their movement skills will be tested on an obstacle course.
- Time commitment
- The study lasts for three visits, with each visit taking place over a short period.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
You may be able to join if
- Are healthy, capacitated adults with binocular constricted visual field loss (due to either retinitis pigmentosa (RP), rod-cone dystrophy, or...
- Have binocular visual acuity or best corrected binocular visual acuity no worse than 6/12 or 20/40 or +0.30 logMAR (inclusive) with no eccentric...
- Are over the age of 18 (inclusive) and has full legal capacity to provide informed consent.
- Have read and fully comprehends the information in the consent letter.
- Are willing and capable of adhering to instructions and maintaining the outlined appointment schedule.
You likely can't join if
- Are involved in other recent eye-related studies, either clinical or research-related. To be eligible they would have to wait at least one week for...
- Have been diagnosed with dementia or self-reported dementia with no formal diagnosis.
- Have been diagnosed with a cognitive impairment or self-reported cognitive impairment with no formal diagnosis.
- Have been diagnosed with physical or motor impairments resulting in walking and/or balancing issues or self-reported physical or motor impairments...
- Have been diagnosed with vestibular disorders or dysfunctions which affects one's balance and/or mobility or self-reported vestibular disorders or...
- Are unable to follow the researcher's instructions.
See the full eligibility criteria
Who can join
- Are healthy, capacitated adults with binocular constricted visual field loss (due to either retinitis pigmentosa (RP), rod-cone dystrophy, or advanced glaucoma) resulting in functional vision losses. These individuals...
- Have binocular visual acuity or best corrected binocular visual acuity no worse than 6/12 or 20/40 or +0.30 logMAR (inclusive) with no eccentric viewing and binocular visual fields no better than 50 degrees in total in...
- Are over the age of 18 (inclusive) and has full legal capacity to provide informed consent.
- Have read and fully comprehends the information in the consent letter.
- Are willing and capable of adhering to instructions and maintaining the outlined appointment schedule.
What rules you out
- Are involved in other recent eye-related studies, either clinical or research-related. To be eligible they would have to wait at least one week for studies not involving brain stimulation, and four weeks for studies in...
- Have been diagnosed with dementia or self-reported dementia with no formal diagnosis.
- Have been diagnosed with a cognitive impairment or self-reported cognitive impairment with no formal diagnosis.
- Have been diagnosed with physical or motor impairments resulting in walking and/or balancing issues or self-reported physical or motor impairments resulting in walking and/or balancing issues with no formal diagnosis.
- Have been diagnosed with vestibular disorders or dysfunctions which affects one's balance and/or mobility or self-reported vestibular disorders or dysfunctions which affects one's balance and/or mobility with no formal...
- Are unable to follow the researcher's instructions.
- Are anticipating treatment (including ocular surgery) for any eye disease within the duration of the study.
- Have any ocular pathology in addition to retinitis pigmentosa (RP), rod-cone dystrophy, or advanced glaucoma, which can diminish their visual acuity and/or their visual field, however wearing glasses or contact lenses...
- Have severe hearing impairment.
- Are pregnant or trying to get pregnant.
- Fit any of the typical contraindicators for brain stimulation. See contraindicator section below. For all participants the contraindications for brain stimulation are:
- Diagnosed with epilepsy or have previously experienced an epileptic seizure.
- Implanted medication pump or implanted electronic device, including defibrillator or pacemaker.
- Any metal implants in the head (excluding tooth fillings).
- Active electric implants anywhere in the body (especially the head region).
- On psychoactive medication for any psychiatric or neurological conditions including but not limited to depression and schizophrenia.
- Areas of sensitive skin located on the face or head, or a skin condition on the face, or regularly use medication to alleviate skin irritation on the face.
- Recurring headaches.
- Previous head injury or skull fracture or head/brain surgery.
- Heart disease, neurological condition, or a history of cardiac or neurological surgery.
- Current or historical cancerous or noncancerous brain tumor, or other abnormalities in brain structure.
The study team makes the final eligibility decision.
Where it's taking place
- Waterloo, Ontario, Canada
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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Waterloo, Ontario, Canada. 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.