Location- and Frequency-Dependent Effects of Thalamic Temporal Interference Stimulation During Sleep

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity of Wisconsin, Madison

About this trial

This study is to find out whether a type of non-invasive electrical brain stimulation called temporal interference transcranial electrical stimulation (TI-TES) can temporarily change brain activity during sleep, especially sleep spindles (brain rhythms in the \~8-16 Hz range). Up to 24 healthy participants in Dane County, Wisconsin will be enrolled for 3 overnight study visits. Participants can expect to be on study for approximately 5 weeks, depending on scheduling availability.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Medically healthy (based on self-report and study team review)

U.S. citizen or holding permanent resident status

English-speaking (able to provide consent and complete questionnaires)

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

Single group

Treatments tested in this trial

  • Magnetic Resonance Imaging (MRI)

    Other intervention

    MRI is to optimize placement of multipolar TI-TES

  • Broad thalamic stimulation (TI-TES)

    Device

    Stimulation targeted at the whole thalamus. Within each overnight session, up to 24 stimulation protocols will be administered, randomized across frequencies (including SHAM). Stimulation will be initiated by trained sleep technicians during stable N2 sleep and delivered in 3-minute epochs separated by 6-minute intervals to enable comparison of PRE, STIM, and POST intervals

  • Carrier only SHAM stimulation

    Device

    Carrier only SHAM condition. Within each overnight session, up to 24 stimulation protocols will be administered, randomized across frequencies (including SHAM). Stimulation will be initiated by trained sleep technicians during stable N2 sleep and delivered in 3-minute epochs separated by 6-minute intervals to enable comparison of PRE, STIM, and POST intervals

  • Anterior thalamic stimulation (TI-TES)

    Device

    Stimulation targeted at the anterior thalamus. Within each overnight session, up to 24 stimulation protocols will be administered, randomized across frequencies (including SHAM). Stimulation will be initiated by trained sleep technicians during stable N2 sleep and delivered in 3-minute epochs separated by 6-minute intervals to enable comparison of PRE, STIM, and POST intervals

  • Posterior thalamic stimulation (TI-TES)

    Device

    Stimulation targeted at the posterior thalamus. Within each overnight session, up to 24 stimulation protocols will be administered, randomized across frequencies (including SHAM). Stimulation will be initiated by trained sleep technicians during stable N2 sleep and delivered in 3-minute epochs separated by 6-minute intervals to enable comparison of PRE, STIM, and POST intervals.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: All ParticipantsExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Change in Spectral Power (SFA) for Active TI-TES vs SHAM

Comparing active TI-TES vs carrier only SHAM, evaluated using both STIM-PRE and POST-PRE contrasts.

Time frame
during each of the 3 overnight visits, 5 weeks
2

Change in SFA by Location

Changes in 8-16 Hz spectral power across frequency-location combinations (broad thalamic, anterior thalamic, posterior thalamic) for STIM-PRE and POST-PRE to identify the most effective parameters within the tested parameter space.

Time frame
during each of the 3 overnight visits, 5 weeks
3

Spindle Density in slow (8-12 Hz) and fast (13-16 Hz) SFA

Changes in slow (8-12 Hz) and fast (13-16 Hz) spindle characteristics (density) using STIM-PRE and POST-PRE contrasts

Time frame
during each of the 3 overnight visits, 5 weeks
4

Spindle Amplitude in slow (8-12 Hz) and fast (13-16 Hz) SFA

Changes in slow (8-12 Hz) and fast (13-16 Hz) spindle characteristics (amplitude) using STIM-PRE and POST-PRE contrasts

Time frame
during each of the 3 overnight visits, 5 weeks

Secondary outcomes

1

Change in Spectral Power (SFA) for SHAM during slow vs fast conditions

Changes in slow (8-12 Hz) and fast (13-16 Hz) spectral power relative to SHAM

Time frame
during each of the 3 overnight visits, 5 weeks
2

Changes in slow-wave spectral power (0.5-4.0 Hz) relative to SHAM

Changes in slow-wave spectral power (0.5-4.0 Hz) relative to SHAM

Time frame
during each of the 3 overnight visits, 5 weeks
3

Changes in Slow-wave Density

Changes in slow-wave characteristics (density) in STIM-PRE and POST-PRE contrasts.

Time frame
during each of the 3 overnight visits, 5 weeks
4

Changes in Slow-wave Amplitude

Changes in slow-wave characteristics (amplitude) in STIM-PRE and POST-PRE contrasts.

Time frame
during each of the 3 overnight visits, 5 weeks

Other outcomes

1

Changes in directed hdEEG functional connectivity

Changes in directed hdEEG functional connectivity measured using the phase slope index (PSI), with effects assessed over stimulation-related intervals (STIM-PRE and POST-PRE).

Time frame
during each of the 3 overnight visits, 5 weeks

Sponsors and contacts

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

University of Wisconsin, Madison

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator