Overcoming the Barriers to Effective Transcranial Temporal Interference Stimulation in Humans

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Northeastern University
Study ID
NCT07593859
Status
Recruiting
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Conditions

  • Healthy Adult Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • transcranial Temporal Interference Stimulation — DEVICE
    We will apply temporal interference stimulation (tTIS) for 20 minutes over the motor cortex concurrent with single-pulse transcranial magnetic stimulation (TMS) (also over the motor cortex). Motor evoked potentials will be recorded using electromyography (EMG).

Study Details

Transcranial temporal interference stimulation (TIS) is an emerging novel tool for non-invasive transcranial brain stimulation that holds the potential for focal and steerable neuromodulation, and the possibility to stimulate focally at depth. TIS involves combining two high frequency waveforms to create a waveform with a "beat" frequency that is physiological relevant for neuromodulation. Successful applications to deep brain targets as well as steerability of the stimulation focus have been demonstrated in mice. Numerous recent investigations in humans have shown great clinical potential for this technology, however several questions about the basic mechanism of TIS action remain. The investigators will apply TIS to the motor cortex of humans and use established transcranial magnetic stimulation techniques to assess cortical excitability in relation to the phase of the TIS waveform. Using TMS, the investigators will i) validate that effects of TIS are due to the "beat" frequency and not the high frequency carrier signal, ii) evaluate the effect of the TIS carrier frequency, and iii) evaluate that whether changes in corticospinal excitability outlast the period of stimulation. Knowledge gained from this experiment will provide a basis for the future use of TIS for clinical applications, including informing parameter optimization.

Key Dates

Start date
Feb 1, 2026
Status verified
May 2026
Primary completion
Oct 1, 2029
Completion
Oct 1, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 990-1010 Hz fb
    990-1010 Hz fb
  • Experimental: 1990-2010 Hz fb
    1990-2010 Hz fb
  • Experimental: 1000-1000 Hz fb
    1000-1000 Hz fb
  • Experimental: 2000-2000 Hz fb
    2000-2000 Hz fb
  • Experimental: 20 Hz
    20 Hz
  • Sham Comparator: sham
    sham

Primary Outcome Measure

Online phase-dependent modulation of corticospinal excitability using the relevance value (R.V.) [ Time Frame: Periprocedural ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northeastern UniversityBostonMassachusetts02115-5724
Mathew Yarossi, PhD
[email protected]
7027828483
Mathew Yarossi, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Northeastern University· Boston, MA

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