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Résztvevőt keres itt: KanadaFázis nélkül

Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment

A legfontosabb adatok

Ki végzi
University of Waterloo
Hol
Waterloo (Kanada)A helyszín megnézése
Azonosító
Állapot
Toboroz
Résztvevők
20 fő, tervezett
Kezdés
2026. nov. 1.
Várható befejezés
2027. aug. 31.
A vizsgálat típusa
Beavatkozással járó, 2 csoport
A vizsgált kezelések
  • Active hf-tRNS.
  • Placebo/sham hf-tRNS
A regiszteradat frissítve
2026. november 3.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat olyan felnőtteket keres, akiknek mindkét szemében beszűkült a látótere retinitis pigmentosa, rod-cone dystrophia vagy előrehaladott glaukóma miatt. Azt vizsgálja, javítja-e az enyhe agystimuláció a tájékozódást és a mozgást.

Életkor
18 éves vagy idősebb
Nem
Mindkét nem részt vehet.
A betegség stádiuma
Mindkét szemben beszűkült látótér retinitis pigmentosa, rod-cone dystrophia vagy előrehaladott glaukóma miatt. A látótér szemenként összesen legfeljebb 50 fok.
Korábbi kezelés
Lehet, hogy a résztvevőt mobilitásoktató megtanította a hosszú fehér bot használatára, de lehet, hogy nem. A vizsgálat alatt nem várható szemműtét vagy szemkezelés.
Biomarker vagy leletérték
A látásélesség mindkét szemmel legalább 6/12 vagy 20/40 vagy +0.30 logMAR, külpontos nézés nélkül.

A részvétel fő kizáró okai

  • Demencia vagy kognitív zavar
  • Járási, egyensúlyi vagy vestibularis probléma
  • Más szembetegség, amely rontja a látást, vagy súlyos halláskárosodás
  • Terhesség vagy tervezett teherbeesés
  • Az agystimuláció ellenjavallata, például epilepszia, fémimplantátum a fejben, pacemaker vagy korábbi fejműtét

A regiszter feltételei, szó szerint

Mind a 26 feltétel megnézéseKevesebb

Ki vehet részt

  • 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 with visual impairments can be those who have been previously trained by an Orientation and Mobility (O\&M) specialist to independently travel with the long white cane daily (since the length of the white cane and tip at the base are based on personal preference, they should be willing to use their own white cane for the study), and those who do not necessarily use a cane for travelling
  • 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 as given by the Humphrey Field analyzer and arc perimeter test. The Humphrey Field Analyzer measures static visual field test, whereas the Arc perimeter test measures kinetic visual field test. Measuring kinetic and static visual field would promote a greater understanding of the individual's daily performance
  • 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

Ki nem vehet részt

  • 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)
  • Previous head injury or skull fracture or head/brain surgery
  • 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 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 diagnosis
  • Are anticipating treatment (including ocular surgery) for any eye disease within the duration of the study
  • Have severe hearing impairment
  • 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
  • Heart disease, neurological condition, or a history of cardiac or neurological surgery
  • 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 which they receive brain stimulation before they could participate in this study
  • 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
  • Are unable to follow the researcher's instructions
  • 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, as well as mild cataract of grade 2 or below is acceptable
  • 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:
  • Recurring headaches
  • Current or historical cancerous or noncancerous brain tumor, or other abnormalities in brain structure

Helyszínek itt: Kanada

  • University of Waterloo, School of Optometry and Vision ScienceWaterloo, KanadaContact: Benjamin Thompson, PhDRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

This pilot clinical trial evaluates whether non-invasive brain stimulation improves the orientation and mobility (O\&M) skills of individuals with constricted visual fields in both eyes. The study is composed of three visits. The first visit is meant to confirm eligibility by performing a few clinical tests. Eligible participants will then complete two additional visits, one in which the participants receive active stimulation, and one in which the participants receive placebo (sham) stimulation. Stimulation will be administered in a randomized, double-blind order. To evaluate improvement, various measures of O\&M performance will be assessed on a standardized obstacle course featuring static natural and artificial obstacles at defined intervals after the intervention. We hypothesize that the application of hf-tRNS to V1 will improve the orientation and mobility skills of individuals with constricted visual fields immediately following stimulation as a results of enhanced periphery through modulation of the mechanisms responsible for crowding, thereby reducing crowding effects and improving contrast for individuals with rod-cone dystrophy and RP (genetic conditions), whereas for individuals with glaucoma (a neurogenerative condition), any improvement noted would be attributed to be enhanced processing of visual signal in the affected periphery. The results will inform the design of a future, larger-scale study.

A vizsgálat 2 csoportja

  • Active brain stimulation (study visit 2) and Placebo/Sham (study visit 3)Egyéb csoport

    Participants in this arm will be exposed to active stimulation for 20 minutes whilst seated quietly at treatment session 1 (study visit 2). They will then complete the orientation and mobility (O\&M) course 2-minutes and 30-minutes after stimulation. It is important to note that they will also complete the course before undergoing stimulation. In addition, individuals with constricted visual fields in both eyes who use a white cane for travelling will be encouraged to use their personal cane for the course, whereas those who do not use a cane will complete the course as they naturally would for any travel paths. Forty-eight hours later the same participants in this arm will be exposed to placebo/sham stimulation (study visit 3) and except for the treatment they receive that day, the same protocol from the previous visit will be executed, and the same outcome measures evaluated. Interventions: Active hf-tRNS at treatment (study visit 2); Placebo/sham hf-tRNS (study visit 3).

    Kezelés: Active hf-tRNS. és Placebo/sham hf-tRNS

  • Placebo/sham (study visit 2) and Active brain stimulation (study visit 3)Egyéb csoport

    Participants in this arm will be exposed to placebo/sham stimulation for 20 minutes whilst seated quietly at treatment session 1 (study visit 2). They will then proceed to complete the orientation and mobility (O\&M) course 2-minutes and 30-minutes after stimulation. It is important to note that they will also complete the course before undergoing stimulation. In addition, individuals with constricted visual fields in both eyes who use a white cane for travelling will be encouraged to use their personal cane for the course, whereas those who do not use a cane will complete the course as they naturally would for any travel paths. Forty-eight hours later the same participants in this arm will be exposed to active stimulation (study visit 3) and except for the treatment they receive that day, the same protocol from the previous visit will be executed, and the same outcome measures evaluated. Interventions: Placebo/sham hf-tRNS at treatment (study visit 2); Active hf-tRNS (study visit 3).

    Kezelés: Active hf-tRNS. és Placebo/sham hf-tRNS

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate Non-invasive Brain Stimulation Effects on Orientation and Mobility Performance in Adults With Visual Impairments
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 13.
A regiszteradat frissítve
2026. november 3.