Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy Stress

Outcome Measures

Primary Outcomes (15)

Color-Word Stroop Task
reaction time (msec) measure of cognitive interference
change from pre- to post-intervention in each of the 4 sessions (through study completion, about 1 month total)
Digit Span Task
number of digits recalled, measure of verbal working memory
change from pre- to post-intervention in each of the 4 sessions (through study completion, about 1 month total)
Wisconsin Card Sorting Task
number of correct items, measure of ability to shift set and assesses cognitive flexibility
change from pre- to post-intervention in each of the 4 sessions (through study completion, about 1 month total)
Monetary Incentive Delay Task
number of rewards received, measure of motivation
change from pre- to post-intervention in each of the 4 sessions (through study completion, about 1 month total)
Delay Discounting Task
rate of monetary discounting
change from pre- to post-intervention in each of the 4 sessions (through study completion, about 1 month total)

Study Arms (4)

placebo stressor, sham rTMS

PLACEBO COMPARATOR

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

Drug: Placebo oral tabletDevice: sham rTMS

placebo stressor, active rTMS

EXPERIMENTAL

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

Device: medial prefrontal cortex rTMSDrug: Placebo oral tablet

active stress, sham rTMS

EXPERIMENTAL

Interventions

yohimbine + hydrocortisoneDrug

yohimbine 54mg + hydrocortisone 20mg oral

active stress, active rTMSactive stress, sham rTMS

medial prefrontal cortex rTMSDevice

1 Hz mPFC rTMS

active stress, active rTMS

Eligibility Criteria

Age21 Years - 60 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Age 21-60 yr
Right-handed

Sponsors & Collaborators

Wayne State University
Otherlead

MeSH Terms

Interventions

YohimbineHydrocortisone

Intervention Hierarchy (Ancestors)

Secologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesPregnenedionesPregnenesPregnanesSteroids

Study Officials

Mark K Greenwald, PhD
Wayne State University
STUDY DIRECTOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: sham (inactive) figure of 8 coil for rTMS, and placebo for pharmacological stressor
Purpose: BASIC SCIENCE
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

November 24, 2019

First Posted

November 29, 2019

Study Start

Study Stopped

rTMS of Limbic Circuitry in Stress Modulation in Healthy Volunteers

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (15)

Study Arms (4)

placebo stressor, sham rTMS

placebo stressor, active rTMS

active stress, sham rTMS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

active stress, active rTMS

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (15)

Study Arms (4)

placebo stressor, sham rTMS

placebo stressor, active rTMS

active stress, sham rTMS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

active stress, active rTMS

You may not qualify if:

Data Sharing

Source record