rTMS of Limbic Circuitry in Stress Modulation in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-10

Study Completion Date

2023-04-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will be conducted with healthy male and female participants. Aim 1 will determine during sham repetitive transcranial magnetic stimulation (rTMS) how a drug stressor combination (yohimbine + hydrocortisone) relative to placebo alters : (1a) impulsivity; (1b) mood; and (1c) physiology. Aim 2 will determine whether active rTMS over the medial prefrontal cortex alters the effects of stress-exposure on (2a) decision-making, (2b) mood, and (2c) biomarkers of stress.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study

NCT02231892

Healthy Volunteer

COMPLETED NA

Using rTMS to Explore Neural Mechanisms of Stress-Induced Opioid Use

NCT04181515

Stress Opioid-use Disorder

WITHDRAWN PHASE2

Feasibility and Efficacy of rTMS in Healthy Persons

NCT04074811

Executive Dysfunction Pain Mood

WITHDRAWN NA

Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Panic Disorder With Comorbid Major Depression

NCT00521352

Panic Disorder Major Depressive Disorder

COMPLETED PHASE2

Regulating Homeostatic Plasticity and the Physiological Response to rTMS

NCT03309696

Tinnitus

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will use a double-blind, within-subjects randomized crossover design. Each participant will complete 4 sessions in this two-factor (2x2) combinatorial design: 1Hz medial prefrontal cortex (mPFC) vs. sham repetitive transcranial magnetic stimulation (rTMS) X pharmacological stressor (yohimbine 54mg + hydrocortisone 20mg) vs. placebo, with each session separated by at least 1 week. Participants will be asked not to use alcohol or drugs for 24-hr before arriving at the lab. We expect to complete screen at least 20 individuals to complete 12 individuals in this study. Candidates will first undergo psychiatric and medical screening to rule out contraindications to participation. Once enrolled, each participant will complete, in randomized order, the 4 conditions above. Periodic measures will be collected before and after the rTMS/sham and stress/placebo interventions. These measures will include subjective, behavioral and physiological assessments, as well as saliva and blood samples.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stress Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double-blind, 1Hz mPFC (vs. sham) rTMS X stressor (vs. placebo), 4-session, within-subjects, randomized crossover design

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

sham (inactive) figure of 8 coil for rTMS, and placebo for pharmacological stressor

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo stressor, sham rTMS

placebo stressor is lactose, and sham rTMS is inactive figure of 8 coil

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

placebo stressor

sham rTMS

Intervention Type DEVICE

sham mPFC rTMS

placebo stressor, active rTMS

placebo stressor is lactose, and active rTMS is 1Hz stimulation over the medial prefrontal cortex

Group Type EXPERIMENTAL

medial prefrontal cortex rTMS

Intervention Type DEVICE

1 Hz mPFC rTMS

Placebo oral tablet

Intervention Type DRUG

placebo stressor

active stress, sham rTMS

active stressor is the combination of yohimbine 54mg + hydrocortisone 20mg, and sham rTMS is inactive figure of 8 coil

Group Type EXPERIMENTAL

yohimbine + hydrocortisone

Intervention Type DRUG

yohimbine 54mg + hydrocortisone 20mg oral

sham rTMS

Intervention Type DEVICE

sham mPFC rTMS

active stress, active rTMS

active stressor is the combination of yohimbine 54mg + hydrocortisone 20mg, and active rTMS is 1Hz stimulation over the medial prefrontal cortex

Group Type EXPERIMENTAL

yohimbine + hydrocortisone

Intervention Type DRUG

yohimbine 54mg + hydrocortisone 20mg oral

medial prefrontal cortex rTMS

Intervention Type DEVICE

1 Hz mPFC rTMS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

yohimbine + hydrocortisone

yohimbine 54mg + hydrocortisone 20mg oral

Intervention Type DRUG

medial prefrontal cortex rTMS

1 Hz mPFC rTMS

Intervention Type DEVICE

Placebo oral tablet

placebo stressor

Intervention Type DRUG

sham rTMS

sham mPFC rTMS

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 21-60 yr
* Right-handed
* Males and non-pregnant/non-lactating females
* Cognitively intact (total IQ score \>80 on Shipley Institute of Living Scale)
* Screening cardiovascular indices must be within ranges that allow for safe use of stressor: resting HR 50-90 bpm, systolic BP 90-140 mmHg, and diastolic BP 50-90 mmHg
* Use alcohol and/or marijuana \<3 times/week; each "time" should consist of \<1 marijuana "joint" equivalent and \<3 alcoholic drinks

Exclusion Criteria

* Under influence of any substance during session
* Past 7-day use of illicit drugs (excluding marijuana) based on Timeline Followback interview
* Urine positive for opioids, cocaine metabolites, benzodiazepines, barbiturates, amphetamines or pregnancy
* Medical conditions prohibiting use of rTMS (e.g. seizure history; using validated rTMS screening instrument)
* Lifetime diagnosis of: psychotic disorder, bipolar disorder, generalized anxiety disorder, obsessive compulsive disorder, or major depression that is not substance-induced
* Past-year substance use disorder
* Medical conditions making it unsafe for participation (e.g. neurological, cardiovascular, pulmonary, or systemic diseases)
* Lactose intolerance (placebo dose)
* Any prohibited medications: medications that lower seizure threshold, psychiatric medications, prescription pain medications, or blood pressure medications
* Chronic head or neck pain
* Taken part in any research studies in the past month

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes