Retinitis Pigmentosa study: Active hf-tRNS.
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
- This study is testing whether non‑invasive brain stimulation improves orientation and mobility skills in people with narrowed visual fields.
- Who it's for
- You may be able to join if you are an adult with retinitis pigmentosa, rod‑cone dystrophy, glaucoma, or other low vision that limits side vision.
- What's involved
- You will come to the clinic three times. The first visit checks if you qualify. Then you will receive real brain stimulation once and a pretend stimulation once, in random order, without knowing which is which. After each session you will walk an obstacle course to see any changes.
- Time commitment
- The study lasts about three visits over a few weeks, each visit a few hours long.
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.
- 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.
- 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 visual fields no better than 50 degrees in total in each eye...
- 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.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Waterloo, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.