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Mechanistic Validation of Human Multipolar TES-TI: Amplitude Modulation, Frequency, and Benchmarking

ConditionTranscranial Electric Stimulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Wisconsin, Madison

About this trial

This study is to find out whether and how a type of non-invasive electrical brain stimulation called transcranial electrical stimulation with temporal interference (TES-TI) can temporarily change brain activity in healthy adults. A structural MRI scan will be used to customize where the stimulation electrodes are placed for each participant to deliver TES-TI during three afternoon sessions at rest with eyes closed. Brain activity is recorded with high-density EEG. Up to 24 participants will be enrolled and on study for 3 to 12 weeks.

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

Current or past history of clinically significant neurological disorder or acquired neurological disease (e.g., stroke, traumatic brain injury), including intracranial lesions (including clinically significant findings identified on the structural MRI)

History of inpatient psychiatric hospitalization

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

Current poorly controlled headaches, including intractable or frequent migraines

Trial design

Design model

Crossover

Treatments tested in this trial

  • TES-TI with hdEEG

    Device

    4 conditions per session. Each condition will follow a standardized block structure consisting of 3 minutes pre-stimulation baseline, 3 minutes stimulation, and 3 minutes post-stimulation recording (PRE, STIM, POST)

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: Session A: Amplitude Modulation SpecificityExperimental treatment 1 intervention
Group B: Session B: BenchmarkingExperimental treatment 1 intervention
Group C: Session C: Frequency DependenceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in band-limited, topography-resolved EEG spectral power during stimulation for conditions in Session A

Change in band-limited, topography-resolved EEG spectral power during stimulation (STIM-PRE) for in-phase mTI compared to SHAM, HF control, and the mixed unipolar+HF condition.

Time frame
data collected for 3 minutes prior to stimulation and 3 minutes during stimulation for each of 4 conditions during Session A (approximately 3 hours long)
2

Change in band-limited, topography-resolved EEG spectral power during stimulation for conditions in Session B

Change in band-limited, topography-resolved EEG spectral power during stimulation (STIM-PRE) for in-phase mTI compared to unipolar TES-TI at 5 mA, and 8 mA, relative to SHAM.

Time frame
data collected for 3 minutes prior to stimulation and 3 minutes during stimulation for each of 4 conditions during Session B (approximately 3 hours long)
3

Change in band-limited, topography-resolved EEG spectral power during stimulation for conditions in Session C

Change in band-limited, topography-resolved EEG spectral power during stimulation (STIM-PRE) for in-phase mTI at 10 Hz, 50 Hz, and 130 Hz, relative to SHAM.

Time frame
data collected for 3 minutes prior to stimulation and 3 minutes during stimulation for each of 4 conditions during Session C (approximately 3 hours long)

Secondary outcomes

1

Change in band-limited, topography-resolved EEG spectral power in the post-stimulation interval (POST-PRE) across all tested conditions

Change in band-limited, topography-resolved EEG spectral power in the post-stimulation interval (POST-PRE) across all tested conditions (in-phase mTI, mixed unipolar+HF, HF control, unipolar 5 mA, unipolar 8 mA; and 10/50/130 Hz where applicable), each evaluated relative to SHAM.

Time frame
data collected for 3 minutes prior to stimulation and 3 minutes post stimulation for each of 4 conditions during each of 3 sessions (each session is approximately 3 hours long, with at least one week between sessions)

Other outcomes

Sponsors and contacts

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

University of Wisconsin, Madison

Lead sponsor

Source ClinicalTrials.gov
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