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Estudo Piloto dos Efeitos da Estimulação Cerebral nas Competências de Orientação e Mobilidade em Adultos com Deficiência Visual.

29 de outubro de 2026 atualizado por: Ben Thompson, University of Waterloo

Um Estudo Piloto Randomizado, Duplamente Cego e Controlado por Placebo para Avaliar os Efeitos da Estimulação Cerebral Não Invasiva no Desempenho da Orientação e Mobilidade em Adultos com Deficiências Visuais.

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

This within-subject crossover pilot study involves applying a weak focused electrical current to the head, to target areas of visual processing, more specifically the primary visual cortex (V1) within the occipital pole. The purpose of this study is to investigate the efficacy of high-frequency transcranial random noise stimulation (hf-tRNS), a safe and well-established form of brain stimulation on O&M performance of individuals with constricted visual fields in both eyes due to either retinitis pigmentosa (RP), rod-cone dystrophy, or advanced glaucoma.

Participants will be recruited from university-affiliated clinics as well as local clinical practices. After obtaining full informed consent at the first visit, participants will complete clinical tests to confirm that the eligibility criteria of the study are met. These tests include measuring the participant's corrected binocular distance and near visual acuities, binocular contrast sensitivity, binocularity, as well as peripheral visual fields. Researchers will also ensure that it safe for the participant to undergo brain stimulation using a list of contraindicators for brain stimulation interventions and verify that participants are free from physical or motor impairments as well as vestibular disorders or dysfunctions that can impact the participant's walking and balancing abilities.

During the two subsequent visits, the effects of stimulation (which lasts 20 minutes) will be studied 2 and 30 minutes after stimulation. To evaluate improvement, various measures of O&M performance will be targeted as participants complete an O&M course divided into 4 sections and composed of an array of static natural and artificial (man-made) obstacles. Participants will be instructed to walk along the various sections at a comfortable pace, safely negotiating the obstacles without touching any of the obstacles. Participants will also be told in which sections obstacles will be encounter. Static natural obstacles refer to fixed/steady/stable obstacles that are either readily found in the environment (e.g., potted plants) or form part of the architecture of the building (e.g., a pole or a sealed doorway). Artificial obstacles will be made of light material such as polystyrene, rubber foam, soft cardboard, burlap, light plastic, or paper. Static natural/real obstacles will be at foot level, foot to knee height, as well as shoulder and head heights, whereas artificial obstacles will be placed either above the knee, waist, at the shoulder or head height. Individuals with constricted field loss in both eyes who use a long white cane for travelling and have received O&M training (including caning skills) from an orientation and mobility professional will be asked to complete the course with their cane. However, individuals with constricted visual field in both eyes who do not use a cane can also complete the same course.

Measures of performance include the primary outcome measure percentage preferred walking speed (PPWS), that is the walking speed of the individual who is visually impaired in an environment with obstacles expressed as a percentage of their preferred walking speed in an unobstructed path. Secondary outcome measures include: the time taken to complete each of the 4 sections of the course, visual detection distance (VDD) (the distance at which an individual detects an obstacle in the travel path, even if it cannot be identified), and visual identification distance (VID) (the distance at which an individual can correctly identify an obstacle in the travel path).

Course section #1 will not consist of obstacles. The time taken to complete the course section, and preferred walking speed in an unobstructed path (obtained from the completion time and length of the straight, flat path) will be measured.

Course section #2 will consist of obstacles and will be an indoor space leading to a more opened space within the building. The time taken to complete the course section, and preferred walking speed in an obstructed path (obtained from the completion time and length of the path) will be measured. The percentage preferred walking speed (PPWS) will be calculated. PPWS is the preferred walking speed of the individual in course section #2 expressed as a percentage of the participant's preferred walking speed in course section #1.

Course sections #3 and #4 will be used for measuring VDD and VID. Each course will be a straight indoor corridor consisting of only one obstacle, and the obstacle will be different for each of the two sections. Moreover, course section #3 will be used as a training course for measuring VDD and VID. The time taken to complete the course section, visual detection distance (VDD), and visual identification distance (VID) will be measured in course sections #3 and #4.

It is important to note that for course section # 2, the location of the obstacles in each trial (pre, post 1, and post 2) will not be varied, but rather the location of the obstacles on each treatment day will be randomized. Moreover, given that courses 3 and 4 only have one obstacle each, it would also help to change what the actual object is for both courses for each trial on both treatment days, as well as the distance they are positioned. Therefore, with respect to courses 3 and 4, each participant will have to detect and hence identify a total of 12 single obstacles. In addition, two researchers will always be with the participant at all times. One will be with the participant to provide instructions and record data; whilst the other will be ahead of the participant to make sure the path is clear, record the times, and confirm that the obstacles are still in place (when applicable).

There will be two stimulation sessions (one with active stimulation and one with placebo (the order will be randomized so that neither the participant nor the researcher will know what the subject will receive)). At the two stimulation sessions the primary and secondary outcome measures will be evaluated as the participant completes the O&M course before stimulation (O&M pretest), as well as 2 mins after stimulation (O&M post-test 1/immediately after stimulation), and 30 mins after stimulation (O&M post-test 2/30 minutes after stimulation).

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) who have little to no functional peripheral vision, any improvement noted would be attributed to be enhanced processing of visual signal in the affected periphery. The objective of this study is to improve the fundamental visual processes of individuals with constricted visual fields using hf-tRNS. From a scientific perspective, the investigators hope to discover whether brain stimulation can serve as an additional rehabilitation tool for improving the O&M skills of individuals with constricted visual fields. Investigators expect that participants will experience temporary O&M improvements, however, there will not be any lasting improvements in O&M skills from such a single session within subject study design. If the results of this study show a positive effect, the data will be used to power a larger study. All procedures will occur at the Human Visual Neuroscience Laboratory, University of Waterloo, Ontario, Canada.

Tipo de estudo

Intervencional

Inscrição (Estimado)

20

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

    • Ontario
      • Waterloo, Ontario, Canadá, N2L 3G1
        • Recrutamento
        • University of Waterloo, School of Optometry and Vision Science
        • Contato:
        • Contato:
        • Investigador principal:
          • Benjamin Thompson, PhD
        • Subinvestigador:
          • Melanie A Mungalsingh, PhD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 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 diagnosis.
  • 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, as well as mild cataract of grade 2 or below is acceptable.
  • 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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: Active brain stimulation (study visit 2) and Placebo/Sham (study visit 3)

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).

Active hf-tRNS: A weak alternating electric current is applied to the head through two electrodes to affect the cortical excitability of the targeted cells in the brain.

Stimulation instrument: neuroConn DC Stimulator Plus 2019 (Direct current stimulator Model number 0021, power: 1.2 W, charger: 2.9 V (maximum 160 mA)) (neurocaregroup.com), or neuroConn DC Stimulator MC 2016 (Multi-channel stimulator Model number 0028, power: 24 W, rating: 12 V (maximum 2 A)) (neurocaregroup.com).

Placebo/sham hf-tRNS: The tRNS machine will be used as in active stimulation, except the electrical current will not be applied.

Stimulation instrument: neuroConn DC Stimulator Plus 2019 (Direct current stimulator Model number 0021, power: 1.2 W, charger: 2.9 V (maximum 160 mA)) (neurocaregroup.com), or neuroConn DC Stimulator MC 2016 (Multi-channel stimulator Model number 0028, power: 24 W, rating: 12 V (maximum 2 A)) (neurocaregroup.com).

Outro: Placebo/sham (study visit 2) and Active brain stimulation (study visit 3)

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).

Active hf-tRNS: A weak alternating electric current is applied to the head through two electrodes to affect the cortical excitability of the targeted cells in the brain.

Stimulation instrument: neuroConn DC Stimulator Plus 2019 (Direct current stimulator Model number 0021, power: 1.2 W, charger: 2.9 V (maximum 160 mA)) (neurocaregroup.com), or neuroConn DC Stimulator MC 2016 (Multi-channel stimulator Model number 0028, power: 24 W, rating: 12 V (maximum 2 A)) (neurocaregroup.com).

Placebo/sham hf-tRNS: The tRNS machine will be used as in active stimulation, except the electrical current will not be applied.

Stimulation instrument: neuroConn DC Stimulator Plus 2019 (Direct current stimulator Model number 0021, power: 1.2 W, charger: 2.9 V (maximum 160 mA)) (neurocaregroup.com), or neuroConn DC Stimulator MC 2016 (Multi-channel stimulator Model number 0028, power: 24 W, rating: 12 V (maximum 2 A)) (neurocaregroup.com).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage preferred walking speed (PPWS)
Prazo: The pre-test and post-tests will take roughly 2 hours to complete.
  • Change in Percentage preferred walking speed (PPWS (%)) before and right after (2 mins) active stimulation.
  • Change in Percentage preferred walking speed (PPWS (%)) before and 30-minutes after active stimulation.
  • Change in Percentage preferred walking speed (PPWS (%)) before and right after (2 mins) placebo/sham stimulation.
  • Change in Percentage preferred walking speed (PPWS (%)) before and 30-minutes after placebo/sham stimulation.
  • Behavioural Measure: The participant will first complete section #1, which is obstacle free. The time taken to complete the section and preferred walking speed in an unobstructed path (obtained from the completion time and length of the straight, flat path) will be measured. They will then proceed to complete section #2, which has obstacles. The time taken to complete the section, and preferred walking speed in an obstructed path will be measured. PPWS= (preferred walking speed course 1/ preferred walking speed course 2)*100.
The pre-test and post-tests will take roughly 2 hours to complete.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Visual detection distance (VDD)
Prazo: The pre-test and post-tests will take roughly 2 hours to complete.
  • Change in Visual detection distance (VDD (m)) before and right after (2 mins) active stimulation.
  • Change in Visual detection distance (VDD (m)) before and 30-minutes after active stimulation.
  • Change in Visual detection distance (VDD (m)) before and right after (2 mins) placebo/sham stimulation.
  • Change in Visual detection distance (VDD (m)) before and 30-minutes after placebo/sham stimulation.
  • Behavioural Measure: Participants will be instructed to walk along the various sections at a comfortable pace, safely negotiating the obstacle without touching any of them. The participant will complete sections #3 and #4. Each section will be a straight indoor corridor consisting of only one obstacle. Moreover, section #3 will be used as a training course, whereas section #4 is meant to collect data. The time it takes to first detect the obstacle and the distance from the participant to the obstacle, the moment it is first detected will be measured. This distance is VDD.
The pre-test and post-tests will take roughly 2 hours to complete.
Visual identification distance (VID)
Prazo: The pre-test and post-tests will take roughly 2 hours to complete.
  • Change in Visual identification distance (VID (m)) before and right after (2 mins) active stimulation.
  • Change in Visual identification distance (VID (m)) before and 30-minutes after active stimulation.
  • Change in Visual identification distance (VID (m)) before and right after (2 mins) placebo/sham stimulation.
  • Change in Visual identification distance (VID (m)) before and 30-minutes after placebo/sham stimulation.
  • Behavioural Measure: Participants will be instructed to walk along the various sections at a comfortable pace, safely negotiating the obstacle without touching any of them. The participant will complete sections #3 and #4. Each section will be a straight indoor corridor consisting of one obstacle. Section #3 will be used for training, whereas section #4 is meant to collect data. The time it takes to correctly identify the obstacle just detected, and the distance from the participant to the obstacle, the moment they first identify it will be measured (VID).
The pre-test and post-tests will take roughly 2 hours to complete.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Benjamin Thompson, PhD, University of Waterloo

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de novembro de 2026

Conclusão Primária (Estimado)

31 de agosto de 2027

Conclusão do estudo (Estimado)

31 de agosto de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

5 de janeiro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de janeiro de 2026

Primeira postagem (Real)

14 de janeiro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de outubro de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • REB #47153

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

The IPD which underlie results in a publication will be made available after deidentification upon reasonable requests to the research team.

Prazo de Compartilhamento de IPD

The IPD will be available upon publication, and no more than 9 months after the publication.

Critérios de acesso de compartilhamento IPD

The IPD will be shared to researchers who provide a methodologically sound proposal.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .