Visual ImpairmentR4VNCT05220449
Re-Orchestration of Interregional Oscillatory Activity to Promote Visual Recovery
A study testing Cross-frequency dual-site tACS in people with Visual Impairment and Stroke, run by Ecole Polytechnique Fédérale de Lausanne at 1 site in Switzerland.
Trial summary
This project assesses the effect of bifocal cross-frequency transcranial alternating current stimulation (tACS) combined with visual training to improve visual recovery and orchestrated oscillatory activity in stroke patients suffering from visual field defects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Visual Impairment, Stroke, Parkinson Disease
- What is being tested?
- Cross-frequency dual-site tACS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2017to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the patient can consent for themselves;
- age 18+ years old;
- at least 7 days since diagnosis "stroke".
- Patients should demonstrate a clear deficit in either simple or complex visual perception in portions of their visual field
Who cannot join
- Diminished capacity to consent;
- Pregnancy
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant,
- Non-compliance to the instructions of the experimenter or an inappropriate behavior hindering the normal progress of the experiment.
- Previous enrolment into the current study
- Exclusion criteria of MRI, tACS, TMS
- Use of psychoactive medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individualized Brain Stimulation to Improve Functional Rehabilitation in Two Models of Sensorimotor Disorders: Stroke and Parkinson's Disease
This project assesses the effect of bifocal cross-frequency transcranial alternating current stimulation (tACS) combined with visual training to improve visual recovery and orchestrated oscillatory activity in stroke patients suffering from visual field defects.
- Conditions
- Visual Impairment, Stroke, Parkinson Disease
- Being tested
- Cross-frequency dual-site tACS
- Keywords
- Stroke, Visual field, Oscillations, tACS, Parkinson's Disease
- Medical subject headings
- Vision Disorders, Stroke, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-frequency dual-site tACSOther
Dual site transcranial alternating current stimulation over the primary visual cortex (V1) and the mediotemporal cortex (MT/V5) using two different stimulation frequencies (Alpha and Gamma)
| Study group | Role | What they receive |
|---|---|---|
| Cf-tACS (V1-Alpha_V5-Gamma) | Active comparator | Not described Receives: Other: Cross-frequency dual-site tACS |
| Cf-tACS (V1-Gamma_V5-Alpha) | Experimental | Not described Receives: Other: Cross-frequency dual-site tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in visual field functions
Comparison of the systematic measurement of the visual field using Humphrey perimetry
Measured: Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
Secondary outcomes (4)
Changes in motion discrimination and integration performances
Comparison of the motion coherence threshold extracted from a two forced-choice direction discrimination task
Measured: Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
Changes in inter-areal cross-frequency interaction
Comparison of the inter-areal Alpha-Gamma coupling using electroencephalography recordings
Measured: Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
Changes in visual tracts integrity
Comparison of the diffusion weigted imaging-based tractography of the main visual tracts
Measured: Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
Changes in functional connectivity within the broad visual network
Functional MRI based connectivity analyses using DCM or graph theory will perfomed
Measured: Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start1 Sep 2017
- Primary completion1 Aug 2023
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ecole Polytechnique Fédérale de Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Estelle Raffin, Ecole Polytechnique Fédérale de Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220449
- Sponsor's protocol ID
- 2017-01761
- Other IDs
- 2017
- Acronym
- R4V
- Status last verified
- Aug 2024
- First submitted
- 30 Nov 2021
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Brain Stimulation to Improve Functional Rehabilitation in Two Models of Sensorimotor Disorders: Stroke and Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05220449
- Acronym / sponsor ID
- R4V / 2017-01761
- Conditions
- Visual Impairment, Stroke, Parkinson Disease
- Keywords
- Stroke, Visual field, Oscillations, tACS, Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ecole Polytechnique Fédérale de LausanneUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project assesses the effect of bifocal cross-frequency transcranial alternating current stimulation (tACS) combined with visual training to improve visual recovery and orchestrated oscillatory activity in stroke patients suffering from visual field defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cf-tACS (V1-Alpha_V5-Gamma) | Active comparator | Other: Cross-frequency dual-site tACS |
| Cf-tACS (V1-Gamma_V5-Alpha) | Experimental | Other: Cross-frequency dual-site tACS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- the patient can consent for themselves;
- age 18+ years old;
- at least 7 days since diagnosis "stroke".
- Patients should demonstrate a clear deficit in either simple or complex visual perception in portions of their visual field
Key exclusion criteria (8 listed)
- Diminished capacity to consent;
- Pregnancy
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant,
- Non-compliance to the instructions of the experimenter or an inappropriate behavior hindering the normal progress of the experiment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cross-frequency dual-site tACSDual site transcranial alternating current stimulation over the primary visual cortex (V1) and the mediotemporal cortex (MT/V5) using two different stimulation frequencies (Alpha and Gamma) | Other | Cf-tACS (V1-Alpha_V5-Gamma), Cf-tACS (V1-Gamma_V5-Alpha) |
Primary outcome
Changes in visual field functions
Time frame: Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
Comparison of the systematic measurement of the visual field using Humphrey perimetry
4 secondary outcomes
Changes in motion discrimination and integration performances
Time frame: Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
Changes in inter-areal cross-frequency interaction
Time frame: Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
Changes in visual tracts integrity
Time frame: Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
Changes in functional connectivity within the broad visual network
Time frame: Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cross-frequency dual-site tACS in people with Visual Impairment and Stroke, run by Ecole Polytechnique Fédérale de Lausanne at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in visual field functions (time frame: Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.