Visual AcuityTINCT03747601
Temporal Interference Brain Stimulation
A study testing Temporal Interference (TI) Stimulation in people with Visual Acuity, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The primary aim of this study is to translate temporal interference (TI) stimulation methodology into humans and examine its safety, feasibility, steerability, and focality. In the proposed early phase human experiment, the ability to apply TI stimulation will be assessed along spatial dimensions to selectively… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- Temporal Interference (TI) Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2019to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal healthy volunteer
- 18-35 years of age
- Normal vision
- Right handed
Who cannot join
- Corrected-to-Normal vision, or visual impairment.
- Any current or past history of a psychiatric disorder
- Any current or past history of neurological disorders or acquired neurological disease (e.g. stroke, traumatic brain injury), including intracranial lesions
- History of head trauma resulting in prolonged loss of consciousness; or a history of >3 grade I concussions
- Current history of poorly controlled headaches including intractable or poorly controlled migraines
- Any systemic illness or unstable medical condition that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
Show all 14Show fewer
- History of fainting spells of unknown or undetermined etiology that might constitute seizures
- History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG, or family history of treatment resistant epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist
- Possible pregnancy. All female participants of child bearing age are required to have a pregnancy test
- Any metal in the brain, skull or elsewhere unless approved by the responsible MD
- Any medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the responsible MD
- Substance abuse or dependence within the past six months
- Pregnancy; all female participants of child bearing age will be required to have a pregnancy test; any participant who is pregnant will not be enrolled in the study.
- Not on any medications with the exception of birth control unless approved by the responsible MD.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: The Development and Human Translation of Temporal Interference Brain Stimulation
The primary aim of this study is to translate temporal interference (TI) stimulation methodology into humans and examine its safety, feasibility, steerability, and focality. In the proposed early phase human experiment, the ability to apply TI stimulation will be assessed along spatial dimensions to selectively modulate neural activity and assess the feasibility of selective targeting deep brain structures without exciting overlaying cortex. The overall goal of the study is to advance TI methodology and its translation to humans.
The specific aims in this study are to
Read more
- Assess the safety of TI stimulation.
- Assess the feasibility, focality, and steerability of TI stimulation by selectively modulating activity in subregions of a cortical area (calcarine cortex)
It is hypothesized that TI stimulation can be used to impact different regions of the visual field that are represented within the calcarine fissure of the human brain.
It is hypothesized that TI will be well tolerated by human subjects and side effects will be consistent with other forms of transcranial electric current stimulation (tES).
Read the detailed description
This is an investigational early phase testing of temporal interference (TI) stimulation in humans. The overall aim of the study is to assess the safety, feasibility, focality, and steerability of TI stimulation by selectively modulating activity in subregions of a cortical area (calcarine cortex - the primary visual cortex)
Healthy subjects who meet inclusion and exclusion criteria will be entered into the study. The study will recruit up to 20 subjects with the aim to complete 12 subjects.
Study Visits:
The study will consist of up to 6 study visits. The screening and baseline visit, the MRI visit, and up to 4 TI study. The screening and baseline visit and TI visits will occur at Beth Israel Deaconess Medical Center in the Berenson-Allen Center. The MRI visit will take place at the Boston University Cognitive Neuroimaging Center. After Informed Consent is obtained, the following screening and baseline procedures will be completed:
- Inclusion and exclusion criteria review
- Subject demographics
- Handedness assessment
- Medical history and medication review
- Physical and Neurological exam conducted by a Neurologist or Neurologic Nurse Practitioner
- Baseline perimetry assessment
- Baseline EEG
- The Mini International Neuropsychiatric Interview (MINI) assessment
- All female subjects will undergo a pregnancy test and pregnant women will be excluded
- Screening for retinotopic mapping - assessing the participant's ability to hold fixation with their eyes for experimental trials
- MRI safety review
The MRI session will take place at the Boston University Cognitive Neuroimaging Center under a Boston University submitted and approved protocol that is specific to this study. An MRI scan of the brain will be conducted while the participant views visual stimuli to obtain each individual's retinotopic map. This data will be provided to the study team at Beth Israel Deaconess Medical Center (BIDMC) to conduct the study visit and for analysis.
Each subject will then undergo up to 4 TI stimulation sessions (2 minimum) separated by at least 2 days to minimize the risk of carry over effects of the stimulation. In each visit, the participant will receive TI stimulation to one of four regions of retinotopic representation in the calcarine fissure:
- peripheral visual field in the deep region of the fissure
- foveal visual field in the polar region of the fissure
- superior quadrant of the visual field in the lower bank of the fissure
- inferior quadrant of the visual field in the upper bank of the fissure The cortical targets will be defined by electrical field modelling that will be used to optimize the electrode placement. Regions #1 and #2 will be stimulated in the first two visits with the order of stimulation regions to be counterbalanced between participants. If an effect is noted, participants will be asked to complete the additional 2 visits in which regions #3 and #4 will be stimulated.
Each visit will consist of up to 4 blocks of stimulation paired with a visual discrimination task and assessment of visual disturbance with an Amsler grid. The stimulation blocks will each be completed at a different frequency - a control stimulation where TI visual effect is not anticipated (e.g 2 or 20 hertz (Hz)), a no offset stimulation (e.g. matched carrier stimulation frequencies such as no envelope modulation is anticipated) and up to 2 frequencies ranging from 8 to 12. The most common signal from visual cortex during wakeful relaxation is in the frequency range (8-12 Hz). It is hypothesized that TI with a residual effective stimulation frequency of 1-20 Hz will be ideally suited for activation of the targeted visual cortex.
Participants will be monitored throughout he visit for any adverse effects and a tES side-effect questionnaire will be administered at the beginning and end of each stimulation visit to additionally track any adverse effects. Although any visual disruption induced by the stimulation is expected and anticipated to be transient in nature, a visual perimetry assessment will be completed to compare to baseline.
- Conditions
- Visual Acuity
- Being tested
- Temporal Interference (TI) Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal Interference (TI) StimulationDevice
2-4 Temporal Interference stimulation sessions. The device is an experimental non-invasive electrical brain stimulator that functions similar to existing non-significant risk devices for electrical stimulation, including human non-invasive brain stimulation. Briefly, the device produces alternating current electrical stimulation in a kilohertz (kHz) range and results in less net charge applied within the brain. The device is powered by rechargeable 20 volt (V) battery (i.e. there is no connection to building power supply). The current is hardwired and limited to 5 milliamp (mA) via internal resistors. It includes extra safety features such as onboard fuses to limit any abrupt high current, and an emergency stop button which effectively insulates the subject and resets the device. The device was tested and characterized at all the required load conditions.
| Study group | Role | What they receive |
|---|---|---|
| Temporal Interference (TI) Stimulation | Experimental | Temporal Interference stimulation applied to the head via standard electrodes Receives: Device: Temporal Interference (TI) Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With a Change in Their Visual Field
Number of participants who had a change in their visual field (scitoma) as assessed by a neurophthalmologist.
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start19 Sep 2019
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Visual AcuityStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University
- Responsible party
- Principal investigator, Daniel Press, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747601
- Sponsor's protocol ID
- 2018P000603
- Acronym
- TI
- Status last verified
- May 2025
- First submitted
- 19 Sep 2018
- Last updated
- 25 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Human Translation of Temporal Interference Brain Stimulation
- ClinicalTrials.gov ID
- NCT03747601
- Acronym / sponsor ID
- TI / 2018P000603
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Boston University
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Posted 25 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to translate temporal interference (TI) stimulation methodology into humans and examine its safety, feasibility, steerability, and focality. In the proposed early phase human experiment, the ability to apply TI stimulation will be assessed along spatial dimensions to selectively modulate neural activity and assess the feasibility of selective targeting deep brain structures without exciting overlaying cortex. The overall goal of the study is to advance TI methodology and its translation to humans.
The specific aims in this study are to
- Assess the safety of TI stimulation.
- Assess the feasibility, focality, and steerability of TI stimulation by selectively modulating activity in subregions of a cortical area (calcarine cortex)
It is hypothesized that TI stimulation can be used to impact different regions of the visual field that are represented within the calcarine fissure of the human brain.
It is hypothesized that TI will be well tolerated by human subjects and side effects will be consistent with other forms of transcranial electric current stimulation (tES).
Detailed description
This is an investigational early phase testing of temporal interference (TI) stimulation in humans. The overall aim of the study is to assess the safety, feasibility, focality, and steerability of TI stimulation by selectively modulating activity in subregions of a cortical area (calcarine cortex - the primary visual cortex)
Healthy subjects who meet inclusion and exclusion criteria will be entered into the study. The study will recruit up to 20 subjects with the aim to complete 12 subjects.
Study Visits:
The study will consist of up to 6 study visits. The screening and baseline visit, the MRI visit, and up to 4 TI study. The screening and baseline visit and TI visits will occur at Beth Israel Deaconess Medical Center in the Berenson-Allen Center. The MRI visit will take place at the Boston University Cognitive Neuroimaging Center. After Informed Consent is obtained, the following screening and baseline procedures will be completed:
- Inclusion and exclusion criteria review
- Subject demographics
- Handedness assessment
- Medical history and medication review
- Physical and Neurological exam conducted by a Neurologist or Neurologic Nurse Practitioner
- Baseline perimetry assessment
- Baseline EEG
- The Mini International Neuropsychiatric Interview (MINI) assessment
- All female subjects will undergo a pregnancy test and pregnant women will be excluded
- Screening for retinotopic mapping - assessing the participant's ability to hold fixation with their eyes for experimental trials
- MRI safety review
The MRI session will take place at the Boston University Cognitive Neuroimaging Center under a Boston University submitted and approved protocol that is specific to this study. An MRI scan of the brain will be conducted while the participant views visual stimuli to obtain each individual's retinotopic map. This data will be provided to the study team at Beth Israel Deaconess Medical Center (BIDMC) to conduct the study visit and for analysis.
Each subject will then undergo up to 4 TI stimulation sessions (2 minimum) separated by at least 2 days to minimize the risk of carry over effects of the stimulation. In each visit, the participant will receive TI stimulation to one of four regions of retinotopic representation in the calcarine fissure:
- peripheral visual field in the deep region of the fissure
- foveal visual field in the polar region of the fissure
- superior quadrant of the visual field in the lower bank of the fissure
- inferior quadrant of the visual field in the upper bank of the fissure The cortical targets will be defined by electrical field modelling that will be used to optimize the electrode placement. Regions #1 and #2 will be stimulated in the first two visits with the order of stimulation regions to be counterbalanced between participants. If an effect is noted, participants will be asked to complete the additional 2 visits in which regions #3 and #4 will be stimulated.
Each visit will consist of up to 4 blocks of stimulation paired with a visual discrimination task and assessment of visual disturbance with an Amsler grid. The stimulation blocks will each be completed at a different frequency - a control stimulation where TI visual effect is not anticipated (e.g 2 or 20 hertz (Hz)), a no offset stimulation (e.g. matched carrier stimulation frequencies such as no envelope modulation is anticipated) and up to 2 frequencies ranging from 8 to 12. The most common signal from visual cortex during wakeful relaxation is in the frequency range (8-12 Hz). It is hypothesized that TI with a residual effective stimulation frequency of 1-20 Hz will be ideally suited for activation of the targeted visual cortex.
Participants will be monitored throughout he visit for any adverse effects and a tES side-effect questionnaire will be administered at the beginning and end of each stimulation visit to additionally track any adverse effects. Although any visual disruption induced by the stimulation is expected and anticipated to be transient in nature, a visual perimetry assessment will be completed to compare to baseline.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temporal Interference (TI) Stimulation | Experimental | Device: Temporal Interference (TI) StimulationTemporal Interference stimulation applied to the head via standard electrodes |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Normal healthy volunteer
- 18-35 years of age
- Normal vision
- Right handed
Key exclusion criteria (14 listed)
- Corrected-to-Normal vision, or visual impairment.
- Any current or past history of a psychiatric disorder
- Any current or past history of neurological disorders or acquired neurological disease (e.g. stroke, traumatic brain injury), including intracranial lesions
- History of head trauma resulting in prolonged loss of consciousness; or a history of >3 grade I concussions
- Current history of poorly controlled headaches including intractable or poorly controlled migraines
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 |
|---|---|---|
| Temporal Interference (TI) Stimulation2-4 Temporal Interference stimulation sessions. The device is an experimental non-invasive electrical brain stimulator that functions similar to existing non-significant risk devices for electrical stimulation, including human non-invasive brain stimulation. Briefly, the device produces alternating current electrical stimulation in a kilohertz (kHz) range and results in less net charge applied within the brain. The device is powered by rechargeable 20 volt (V) battery (i.e. there is no connection to building power supply). The current is hardwired and limited to 5 milliamp (mA) via internal resistors. It includes extra safety features such as onboard fuses to limit any abrupt high current, and an emergency stop button which effectively insulates the subject and resets the device. The device was tested and characterized at all the required load conditions. | Device | Temporal Interference (TI) Stimulation |
Primary outcome
Participants With a Change in Their Visual Field
Time frame: Immediately after intervention
Number of participants who had a change in their visual field (scitoma) as assessed by a neurophthalmologist.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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 Temporal Interference (TI) Stimulation in people with Visual Acuity, run by Beth Israel Deaconess Medical Center 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 4 inclusion and 14 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: stopped early, as of the sponsor's last update on 25 May 2025. 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. 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?
Yes. Results are posted in the registry (first posted 25 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participants With a Change in Their Visual Field (time frame: Immediately after 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 25 May 2025.