AmblyopiaNIBSAAMNCT06712849
Noninvasive Brain Stimulation in Adult Amblyopia
A study testing High Frequency Transcranial Random Noise Stimulation in people with Amblyopia, run by Midwestern University at 1 site in United States.
Trial summary
The goal of this randomized controlled trial is to investigate the effectiveness of non-invasive brain stimulation in treating adults with amblyopia. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Amblyopia
- What is being tested?
- High Frequency Transcranial Random Noise Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults between 18 and 55 years of age
- Formal diagnosis of amblyopia in one or both eyes of any etiology
Who cannot join
- History of optic nerve disease, including glaucoma and optic neuritis
- History of neurological conditions, including demyelinating disease or stroke
- Presence of metal or electronic implants in or on the body, including pacemakers
- Taking medications that can affect normal neurological function, including antipsychotics, antiepileptics, and opioids
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Midwestern University Eye Institute
Downers Grove, Illinois, 60515
Sherri Olsen, 630-515-7368, solsen@midwestern.edu
Arijit Chakraborty, PhD
About this study
Official title: Multi-day Effect of Noninvasive Brain Stimulation in Adults With Amblyopia
The goal of this randomized controlled trial is to investigate the effectiveness of non-invasive brain stimulation in treating adults with amblyopia. The main questions it aims to answer are:
- What are the effects of non-invasive brain stimulation on neuronal plasticity in the visual cortex of adults with amblyopia, and does it produce lasting changes?
- Do cumulative sessions of non-invasive brain stimulation influence neural plasticity and higher-order visual functions in adults with amblyopia?
Read more
The investigators hypothesize that non-invasive brain stimulation will show a positive cumulative effect after five (5) consecutive days of stimulation on visual perception and function in adults with amblyopia.
Participants will be randomized into one of two treatment groups:
- High-frequency transcranial random noise stimulation (hf-tRNS).
- Sham stimulation.
Researchers will compare baseline measurements of crowded visual acuity, contrast sensitivity, stereoacuity, phosphene thresholds, global motion perception, form pattern recognition and pattern-reversal visual evoked potentials (VEPs) to post-treatment measurements for each group.
- Conditions
- Amblyopia
- Being tested
- Sham Transcranial Random Noise Stimulation, High Frequency Transcranial Random Noise Stimulation
- Keywords
- Amblyopia, Non-invasive Brain Stimulation, Transcranial Random Noise Stimulation, Visual Perception, Visual Evoked Potentials
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham Transcranial Random Noise StimulationDevice
Also called Sham tRNS
Sham transcranial random noise stimulation will be applied over the primary visual cortex (area V1) with the current ramping up for 20 seconds before ramping down for 20 seconds. The 2.0 milliamp current stimulation will occur for only a few seconds at the start and at the end of the 40 minutes.
High Frequency Transcranial Random Noise StimulationDevice
Also called tRNS, hf-tRNS
Non-invasive brain stimulation will involve the use of high-frequency transcranial random noise stimulation (100-640 Hz) to apply a 2.0 milliamp current over the primary visual cortex (area V1) for approximately 40 minutes with a ramp up to the maximum programmed current and ramp down of 20 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Sham Stimulation | Sham comparator | 40-minute sessions of sham stimulation for 5 consecutive days. Receives: Device: Sham Transcranial Random Noise Stimulation |
| hf-tRNS Stimulation | Active comparator | 40-minute sessions of hf-tRNS stimulation for 5 consecutive days. Receives: Device: High Frequency Transcranial Random Noise Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crowded Visual Acuity
A change in crowded visual acuity is measured in LogMAR from baseline.
Measured: Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).
Stereo Acuity
A change in stereo acuity is measured in arc seconds from baseline.
Measured: Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).
Phosphene Threshold
A change in phosphene threshold (%) from baseline.
Measured: Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).
Global Motion Perception
A change in global motion perception coherence threshold (%) from baseline.
Measured: Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).
Form Pattern Recognition
A change in form pattern recognition coherence threshold (%) from baseline.
Measured: Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).
Pattern-reversal Visual Evoked Potentials (pVEP)
A change in N75-P100 amplitudes and P100 latencies from baseline.
Measured: Pre-treatment (Day 1); post-treatment (Day 5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 May 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Midwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arijit Chakraborty, Midwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712849
- Sponsor's protocol ID
- CIRB-IL 23044
- Acronym
- NIBSAAM
- Status last verified
- Dec 2024
- First submitted
- 27 Nov 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ding Z, Li J, Spiegel DP, Chen Z, Chan L, Luo G, Yuan J, Deng D, Yu M, Thompson B. The effect of transcranial direct current stimulation on contrast sensitivity and visual evoked potential amplitude in adults with amblyopia. Sci Rep. 2016 Jan 14;6:19280. doi: 10.1038/srep19280.
PubMed 26763954Thompson B, Mansouri B, Koski L, Hess RF. Brain plasticity in the adult: modulation of function in amblyopia with rTMS. Curr Biol. 2008 Jul 22;18(14):1067-71. doi: 10.1016/j.cub.2008.06.052.
PubMed 18635353Thompson B, Mansouri B, Koski L, Hess RF. From motor cortex to visual cortex: the application of noninvasive brain stimulation to amblyopia. Dev Psychobiol. 2012 Apr;54(3):263-73. doi: 10.1002/dev.20509. Epub 2010 Nov 8.
PubMed 22415915Clavagnier S, Thompson B, Hess RF. Long lasting effects of daily theta burst rTMS sessions in the human amblyopic cortex. Brain Stimul. 2013 Nov;6(6):860-7. doi: 10.1016/j.brs.2013.04.002. Epub 2013 Apr 28.
PubMed 23664756
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-day Effect of Noninvasive Brain Stimulation in Adults With Amblyopia
- ClinicalTrials.gov ID
- NCT06712849
- Acronym / sponsor ID
- NIBSAAM / CIRB-IL 23044
- Conditions
- Amblyopia
- Keywords
- Amblyopia, Non-invasive Brain Stimulation, Transcranial Random Noise Stimulation, Visual Perception, Visual Evoked Potentials
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Midwestern UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Dec 2024 (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.
The goal of this randomized controlled trial is to investigate the effectiveness of non-invasive brain stimulation in treating adults with amblyopia. The main questions it aims to answer are:
- What are the effects of non-invasive brain stimulation on neuronal plasticity in the visual cortex of adults with amblyopia, and does it produce lasting changes?
- Do cumulative sessions of non-invasive brain stimulation influence neural plasticity and higher-order visual functions in adults with amblyopia?
The investigators hypothesize that non-invasive brain stimulation will show a positive cumulative effect after five (5) consecutive days of stimulation on visual perception and function in adults with amblyopia.
Participants will be randomized into one of two treatment groups:
- High-frequency transcranial random noise stimulation (hf-tRNS).
- Sham stimulation.
Researchers will compare baseline measurements of crowded visual acuity, contrast sensitivity, stereoacuity, phosphene thresholds, global motion perception, form pattern recognition and pattern-reversal visual evoked potentials (VEPs) to post-treatment measurements for each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Stimulation | Sham comparator | Device: Sham Transcranial Random Noise Stimulation40-minute sessions of sham stimulation for 5 consecutive days. |
| hf-tRNS Stimulation | Active comparator | Device: High Frequency Transcranial Random Noise Stimulation40-minute sessions of hf-tRNS stimulation for 5 consecutive days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults between 18 and 55 years of age
- Formal diagnosis of amblyopia in one or both eyes of any etiology
Key exclusion criteria (4 listed)
- History of optic nerve disease, including glaucoma and optic neuritis
- History of neurological conditions, including demyelinating disease or stroke
- Presence of metal or electronic implants in or on the body, including pacemakers
- Taking medications that can affect normal neurological function, including antipsychotics, antiepileptics, and opioids
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 |
|---|---|---|
| Sham Transcranial Random Noise StimulationAlso: Sham tRNSSham transcranial random noise stimulation will be applied over the primary visual cortex (area V1) with the current ramping up for 20 seconds before ramping down for 20 seconds. The 2.0 milliamp current stimulation will occur for only a few seconds at the start and at the end of the 40 minutes. | Device | Sham Stimulation |
| High Frequency Transcranial Random Noise StimulationAlso: tRNS, hf-tRNSNon-invasive brain stimulation will involve the use of high-frequency transcranial random noise stimulation (100-640 Hz) to apply a 2.0 milliamp current over the primary visual cortex (area V1) for approximately 40 minutes with a ramp up to the maximum programmed current and ramp down of 20 seconds. | Device | hf-tRNS Stimulation |
Primary outcome
Crowded Visual Acuity
Time frame: Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).
A change in crowded visual acuity is measured in LogMAR from baseline.
Stereo Acuity
Time frame: Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).
A change in stereo acuity is measured in arc seconds from baseline.
Phosphene Threshold
Time frame: Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).
A change in phosphene threshold (%) from baseline.
Global Motion Perception
Time frame: Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).
A change in global motion perception coherence threshold (%) from baseline.
Form Pattern Recognition
Time frame: Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).
A change in form pattern recognition coherence threshold (%) from baseline.
Pattern-reversal Visual Evoked Potentials (pVEP)
Time frame: Pre-treatment (Day 1); post-treatment (Day 5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).
A change in N75-P100 amplitudes and P100 latencies from baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Background: PubMed 26763954Ding Z, Li J, Spiegel DP, Chen Z, Chan L, Luo G, Yuan J, Deng D, Yu M, Thompson B. The effect of transcranial direct current stimulation on contrast sensitivity and visual evoked potential amplitude in adults with amblyopia. Sci Rep. 2016 Jan 14;6:19280. doi: 10.1038/srep19280.
- Background: PubMed 18635353Thompson B, Mansouri B, Koski L, Hess RF. Brain plasticity in the adult: modulation of function in amblyopia with rTMS. Curr Biol. 2008 Jul 22;18(14):1067-71. doi: 10.1016/j.cub.2008.06.052.
- Background: PubMed 22415915Thompson B, Mansouri B, Koski L, Hess RF. From motor cortex to visual cortex: the application of noninvasive brain stimulation to amblyopia. Dev Psychobiol. 2012 Apr;54(3):263-73. doi: 10.1002/dev.20509. Epub 2010 Nov 8.
- Background: PubMed 23664756Clavagnier S, Thompson B, Hess RF. Long lasting effects of daily theta burst rTMS sessions in the human amblyopic cortex. Brain Stimul. 2013 Nov;6(6):860-7. doi: 10.1016/j.brs.2013.04.002. Epub 2013 Apr 28.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Frequency Transcranial Random Noise Stimulation in people with Amblyopia, run by Midwestern University at 1 site in United States.
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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 12 Dec 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 United States. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arijit Chakraborty, PhD (630-960-3172, achakr@midwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crowded Visual Acuity (time frame: Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06712849, which also lists 4 linked publications.
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 12 Dec 2024.