NCT07593859

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
41mo left

Started Feb 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Feb 2026Oct 2029

Study Start

First participant enrolled

February 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

3.7 years

First QC Date

May 5, 2026

Last Update Submit

May 14, 2026

Conditions

Keywords

transcranial temporal interference stimulation

Outcome Measures

Primary Outcomes (1)

  • Online phase-dependent modulation of corticospinal excitability using the relevance value (R.V.)

    Explained variance (R2) of best-fit sinusoids will be multiplied by the variance of measured values to obtain the established "relevance value" (R.V.), to be used as our primary outcome. Relevance values assume phase-dependent modulation with a large amplitude is more meaningful than one with small amplitude and the same R2. Critically, phase-dependent responses to TIS represent direct evidence of modulation at beat frequency (fb).

    Periprocedural

Secondary Outcomes (2)

  • Offline neuroplastic effects from pre to post

    Periprocedural

  • Offline neuroplastic post effects

    Periprocedural

Study Arms (6)

990-1010 Hz fb

EXPERIMENTAL

990-1010 Hz fb

Device: transcranial Temporal Interference Stimulation

1990-2010 Hz fb

EXPERIMENTAL

1990-2010 Hz fb

Device: transcranial Temporal Interference Stimulation

1000-1000 Hz fb

EXPERIMENTAL

1000-1000 Hz fb

Device: transcranial Temporal Interference Stimulation

2000-2000 Hz fb

EXPERIMENTAL

2000-2000 Hz fb

Device: transcranial Temporal Interference Stimulation

20 Hz

EXPERIMENTAL

20 Hz

Device: transcranial Temporal Interference Stimulation

sham

SHAM COMPARATOR

sham

Device: transcranial Temporal Interference Stimulation

Interventions

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).

1000-1000 Hz fb1990-2010 Hz fb20 Hz2000-2000 Hz fb990-1010 Hz fbsham

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Free of neurological or orthopedic conditions that may impact the ability to participate.
  • Right-hand dominant (self-reported)
  • Aged 18-65 years

You may not qualify if:

  • Ferromagnetic metal implants in the brain/skull or elsewhere (dental implants excluded).
  • Any implanted electronic device (e.g. cardiac pacemaker, cochlear implant, deep brain stimulator, medication infusion pump; vagal nerve stimulator)
  • Diseased or damaged skin on face or scalp
  • History of migraines, fainting, seizures/epilepsy, or psychiatric illness
  • Neurological disorder or intracranial lesion
  • Frequent or severe headaches
  • Prior adverse reaction to transcranial magnetic stimulation
  • Currently pregnant
  • Suspected or diagnosed heart problems (e.g. arrhythmia, cardiac disturbances).
  • Insulin-dependent diabetes
  • Suspected or diagnosed epilepsy or a familial history of epilepsy
  • Use of alcohol or recreational drugs in the prior 12 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02115-5724, United States

RECRUITING

Study Officials

  • Mathew Yarossi, PhD

    Northeastern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanne Hall, M.Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Healthy, right-handed adults (18-65 yo) will participate following institutionally approved informed consent. Participants will be free of neurological diagnoses, head trauma resulting in loss of consciousness, psychiatric or cognitive conditions, and will meet tCS and TMS safety requirements. Throughout all experiments participants will sit comfortably, arms supported at their sides, feet on a foot rest, viewing a dot on the wall facing them. The experiment is a double-blind randomized cross-over study that will include 23-30 individuals. All study conditions will be evaluated in separate sessions, which will be counterbalanced across participants and spaced 48-96 hrs apart to prevent carry-over effects. We will test for phase-dependent and neuroplastic effects of TIS in a controlled study with 6 conditions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 18, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2029

Last Updated

May 18, 2026

Record last verified: 2026-05

Locations