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Temporal Interference Brain Stimulation (TI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03747601
Recruitment Status : Unknown
Verified May 2020 by Beth Israel Deaconess Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : November 20, 2018
Last Update Posted : May 20, 2020
Sponsor:
Collaborator:
Boston University
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center

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).


Condition or disease Intervention/treatment Phase
Visual Acuity Device: Temporal Interference (TI) Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: The Development and Human Translation of Temporal Interference Brain Stimulation
Actual Study Start Date : September 19, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: Temporal Interference (TI) Stimulation
Temporal Interference stimulation applied to the head via standard electrodes
Device: Temporal Interference (TI) Stimulation
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.




Primary Outcome Measures :
  1. Humphrey visual field Mean Deviation (MD) [ Time Frame: Immediately after intervention ]
    Change in the mean deviation (PMD) Humphrey perimetry between baseline and post-stimulation

  2. Change in visual discrimination threshold [ Time Frame: Immediately after intervention ]
    Change in detection thresholds during stimulation compared to before stimulation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal healthy volunteer
  • 18-35 years of age
  • Normal vision
  • Right handed

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03747601


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Boston University
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Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03747601    
Other Study ID Numbers: 2018P000603
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes