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Temporal Interference for Thalamocortical Activity and Network Modulation

ConditionHealthy Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Wisconsin, Madison

About this trial

The goal of this clinical trial is to find out whether a type of electrical brain stimulation, called temporal interference stimulation, can temporarily change the way different parts of the brain communicate with each other.

Participants will:

* Complete two stimulation phases - overnight and during wakefulness * Undergo two MRIs per study phase

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults aged 18-50

Medically healthy

U.S. citizen or holding permanent resident status

English-speaking

Disqualifiers

Any current or past history of neurological disorders or acquired neurological disease (e.g. stroke, traumatic brain injury), including intracranial lesions (including clinically significant findings identified in first MRI)

History of inpatient psychiatric hospitalization

History of head trauma resulting in prolonged loss of consciousness; or a history of greater than 3 grade I concussions

Current history of poorly controlled headaches including intractable or poorly controlled migraines

Trial design

Design model

Parallel

Treatments tested in this trial

  • Temporal Interference Transcranial electrical stimulation (TI-TES)

    Device

    TI-TES uses specific electrode arrangement patterns to selectively stimulate the brain. Participants will wear an hdEEG (high density electroencephalography) cap which will allow intermittent periods of stimulation from TI-TES.

  • Sham stimulation

    Device

    Sham (ramp only) stimulation will briefly ramp up and down at the beginning and end of each stimulation train, without delivering continuous stimulation throughout.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: StimulationExperimental treatment 1 intervention
Group B: Sham stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in thalamocortical functional connectivity (FC): resting state fMRI

Resting-state fMRI will be used to assess changes in thalamocortical functional connectivity before and after repeated thalamic TI-TES delivered during NREM sleep and quiet wakefulness.

Time frame
Pre- to post-intervention, up to 2 weeks
2

Difference in magnitude of FC changes between sleep and wake

The magnitude of FC changes between sleep and wake stimulation phases will be evaluated.

Time frame
8 weeks
3

Difference in spatial distribution of FC changes between sleep and wake

The spatial distribution of FC changes between sleep and wake stimulation phases will be evaluated.

Time frame
8 weeks

Secondary outcomes

1

Change in sigma-band power (EEG, sleep phase)

Sigma band power will be measured with high density EEG (hdEEG) during stimulation, and will be analyzed to quantify stimulation-related changes in sigma-band power during NREM sleep.

Time frame
During and after each overnight stimulation session, up to 1 week
2

Change in alpha band power during wake stimulation sessions

Alpha band power will be measured with hdEEG during stimulation, and will be analyzed to quantify stimulation-related changes in alpha-band power during quiet wakefulness stimulation.

Time frame
During and after each wake stimulation session, up to 1 week
3

Return to baseline thalamocortical FC

After the ≥4-week washout, thalamocortical FC will be assessed by resting-state fMRI prior to the second stimulation phase.

Time frame
8 weeks
4

Change in structural thalamocortical connectivity

Will be measured using diffusion-weighted imaging (DWI) in each phase.

Time frame
Pre- to post-intervention, up to 2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

Brain & Behavior Research Foundation

Collaborator

Source ClinicalTrials.gov
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