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Temporal Interference Methods for Non-invasive Deep Brain Stimulation, Study 1.3

ConditionHealthy Volunteers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorIndiana University

About this trial

This grant aims to develop a line of research using temporal interference (TI) electrical neurostimulation technology to understand the causal role of deep brain structures in cognition. In the short term, the investigators aim to validate and characterize the effects of TI on brain activity as measured by fMRI and demonstrate its ability to focally stimulate deep brain regions without affecting overlying cortex. In the longer term, investigators aim to use these data to resolve longstanding debates about the function of deeper brain regions and lay the foundation for future clinical applications of TI for treating addiction, Obsessive-Compulsive Disorder (OCD), Parkinson's disease, and other disorders involving deep brain dysfunction. The grant supports 2 distinct aims, each of which will be evaluated through a series of independent studies.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Between the ages of 18 and 50

Must have at least a 6th grade education

Ability to speak and read English for all phases

Disqualifiers

Currently taking psychotropic medications for ADHD, other mental illness, or medications for cancer

History of epilepsy or seizure disorders

History of migraines or other neurological syndromes

History of AIDS (due to potential cognitive deficits)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Active

    Device

    Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies at up to ±5 mA per channel, corresponding to 10 mA peak-to-peak. For the dACC 20 Hz TI Active condition, one channel will deliver 2000 Hz and the other 2020 Hz, producing a 20 Hz beat frequency targeting the dorsal anterior cingulate cortex. Stimulation is administered in 2-minute on / 2-minute off cycles with a 30-second ramp up and ramp down beginning at the start of each 2-minute period.

  • Temporal Interference (TI) Electrical Stimulation - dACC 20 Hz TI Sham

    Device

    Same setup as the dACC 20 Hz TI Active condition, except that stimulation immediately ramps down after reaching the target intensity following ramp up, producing a sham condition.

  • Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Active

    Device

    Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies at up to ±5 mA per channel, corresponding to 10 mA peak-to-peak. For the dACC comparison frequency TI Active condition, stimulation will be delivered using a selected beat frequency in the 1-100 Hz range. Stimulation is administered in 2-minute on / 2-minute off cycles with a 30-second ramp up and ramp down beginning at the start of each 2-minute period.

  • Temporal Interference (TI) Electrical Stimulation - dACC Comparison Frequency TI Sham

    Device

    Same setup as the dACC comparison frequency TI Active condition, except that stimulation immediately ramps down after reaching the target intensity following ramp up, producing a sham condition.

Treatment groups

30 Participants
are divided into 4 treatment groups
Group A: dACC 20Hz Active then Sham; Comparison frequency Active then ShamActive comparator 4 interventions
Group B: dACC 20Hz Sham then Active; Comparison Frequency Sham then ActiveActive comparator 4 interventions
Group C: dACC Comparison Frequency Sham then Active; 20Hz Sham then ActiveActive comparator 4 interventions
Group D: dACC Comparison Frequency Active then Sham; 20Hz Active then ShamActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Change in brain activity in the dorsal anterior cingulate cortex during 20 Hz versus selected comparison frequency temporal interference stimulation

Brain activity in the dorsal anterior cingulate cortex will be measured using functional magnetic resonance imaging (fMRI) during temporal interference (TI) stimulation at 20 Hz compared to a selected comparison beat frequency. The comparison frequency will be in the 1-100 Hz range. Activity will be reported as the percent change in blood-oxygen-level-dependent (BOLD) signal, which reflects changes in neural activity. Higher BOLD values indicate stronger brain activation.

Time frame
During fMRI scan on study day (approximately 60 minutes)

Secondary outcomes

1

Change in brain activity in the dorsal anterior cingulate cortex during active versus sham stimulation at 20 Hz

Brain activity in the dorsal anterior cingulate cortex will be measured using fMRI during active versus sham temporal interference stimulation at a 20 Hz beat frequency. Activity will be reported as the percent change in blood-oxygen-level-dependent (BOLD) signal.

Time frame
During fMRI scan on study day (approximately 60 minutes)
2

Change in brain activity in the dorsal anterior cingulate cortex during active versus sham stimulation at the selected comparison frequency

Brain activity in the dorsal anterior cingulate cortex will be measured using fMRI during active versus sham temporal interference stimulation at the selected comparison beat frequency. The comparison frequency will be within the 1-100 Hz range. Activity will be reported as the percent change in blood-oxygen-level-dependent (BOLD) signal.

Time frame
During fMRI scan on study day (approximately 60 minutes)
3

Change in brain connectivity between the dorsal anterior cingulate cortex and other brain regions during temporal interference stimulation

Functional connectivity between the dorsal anterior cingulate cortex and other brain regions will be measured using fMRI-based analyses during active versus sham temporal interference stimulation. Higher correlation values indicate stronger communication between brain regions. The primary test statistic will be the whole-brain psychophysiological interaction (PPI) between dorsal anterior cingulate cortex BOLD activity and stimulation condition.

Time frame
During fMRI scan on study day (approximately 60 minutes)

Other outcomes

Sponsors and contacts

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

Indiana University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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