Temporal Interference Brain Stimulation

NCT03747601 | Terminated Results DMC FDA Device

• 1 other identifier: 2018P000603
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after intervention

Study Arms (1)

Temporal Interference (TI) Stimulation

EXPERIMENTAL

Temporal Interference stimulation applied to the head via standard electrodes

Device: Temporal Interference (TI) Stimulation

Interventions

Temporal Interference (TI) Stimulation DEVICE

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.

Temporal Interference (TI) Stimulation

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal healthy volunteer
• years of age
• Normal vision
• Right handed

You may not qualify if:

• 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.)
• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Boston University: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Results Point of Contact

• Title: Daniel Press, MD Chief of Cognitive Neurology Unit
• Organization: BIDMC

dpress@bidmc.harvard.edu

617-667-4074

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: November 20, 2018
• Study Start: September 19, 2019
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: May 25, 2025
• Results First Posted: May 25, 2025

Record last verified: 2025-05

Locations

US (1)