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Theta Phase-specific TMS to Modulate Prefrontal Activity

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Completed

Conditions

Approach/Avoidance Behavior

Treatments

Device: Transcranial magnetic stimulation (TMS)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05416138
STUDY00016214

Details and patient eligibility

About

The purpose of this study is to evaluate the causal link between the phase of ongoing theta oscillations in the prefrontal cortex and approach/avoidance (Ap/Av) behavior in adults using theta phase-specific transcranial magnetic stimulation (TMS).

Full description

Approach/avoidance (Ap/Av) behavior is a reliable marker of the emotional processes in the human brain and a robust predictor of mood disorders. Although existing scientific studies found a correlation between the approach/avoidance behavior and ongoing theta activity (3-7 Hz) in the left dorsolateral prefrontal cortex, the causal evidence of the phase-dependent role and strength of association between the prefrontal theta oscillations and approach/avoidance behavior are still unclear. Here, we will monitor brain oscillations in real-time non-invasively using electroencephalography during the approach/avoidance test and modulate theta peaks or troughs with transcranial magnetic stimulation. These data will provide novel understanding of the mechanisms of emotional processing in human brain.

Enrollment

26 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Age between 18 and 65 years old.
  2. Confident level of English language.

Exclusion criteria

  1. Chronic condition that requires pharmacological treatment over the course of study participation.
  2. Metallic or electric implant in the head, neck, or chest area or otherwise MRI-noncompatible implants.
  3. History or evidence of seizures, head injuries with loss of consciousness, chronic neurological or mental disorder.
  4. Pregnancy or breast-feeding.
  5. History or evidence of alcohol or drug addiction.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

26 participants in 2 patient groups

TMS over the left prefrontal cortex
Experimental group
Description:
Transcranial magnetic stimulation (TMS) will be administrated with a figure-8 coil over the left dorsolateral prefrontal cortex (DLPFC) at the intensity of up to 120% of the individualized resting motor threshold (rMT). Stimulation will be performed during and for the duration of the cognitive test. Up to three TMS pulses will be delivered at the beginning of every test trial (each trial duration is 2-6 seconds). The total duration of the cognitive testing and stimulation per session is approximately 40 minutes (in 4 blocks with breaks in-between).
Treatment:
Device: Transcranial magnetic stimulation (TMS)
TMS over the head vertex
Sham Comparator group
Description:
Transcranial magnetic stimulation (TMS) will be administrated with a figure-8 coil over the head vertex at the intensity of up to 120% of the individualized resting motor threshold (rMT). Stimulation will be performed during and for the duration of the cognitive test. Up to three TMS pulses will be delivered at the beginning of every test trial (each trial duration is 2-6 seconds). The total duration of the cognitive testing per session is approximately 40 minutes (in 4 blocks with breaks in-between).
Treatment:
Device: Transcranial magnetic stimulation (TMS)

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Alexander Opitz, PhD; Ivan Alekseichuk, PhD

Data sourced from clinicaltrials.gov

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