search
Back to results

A Neurosensory Account

Primary Purpose

Post Traumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
alpha-frequency tACS
Random noise stimulation
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Right-handed With normal or corrected-to-normal vision and normal olfaction Between the ages of 18 and 50 years Meeting the tACS screening criteria (see List I below; e.g., lack of a serious head injury or loss of consciousness) Patients: Diagnosis of PTSD Patients: If taking psychotropic medications, medication stability in the past 2 months If having mild substance use disorder (for patients) or occasional substance use, abstention from use 48 hours before the experiment. Exclusion Criteria: A history of diagnosis for a major medical illness (e.g., cancer, metabolic syndrome, cardiovascular disease, inflammatory disorders) or a neurological disorder (e.g., seizure, stroke, Parkinson's disease). Patients: Concurrent Axis I diagnosis (depression, anxiety, and mild substance use disorder are allowed given their high comorbidity with PTSD). Healthy controls: A history of diagnosis for a DSM-5 Axis I disorder or current use of psychoactive medications. Severe psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal, or any behavior that poses an immediate danger to self or others. History of head trauma with unconsciousness (> 5 minutes) Report that they regularly drink 3 or more alcoholic beverages a day. Report that they are unable to abstain from substance use (including alcohol, nicotine, cannabis, amphetamines, narcotics, solvents, cocaine, hallucinogens, tranquilizers, barbiturates, etc.) or sleep medication for 48 hours before being scanned. Are on calcium channel blockers (e.g., verapamil, nifedipine) or alpha-blockers (e.g., prazosin, terazosin) and are unable to stop these medications for a 48-hour period prior to scanning (to exclude the impact of these medications on the interpretation of fMRI/EEG). Failed Urine Drug Screening Test: A rapid urine screening test that utilizes monoclonal antibodies to detect elevated levels of specific drugs (including alcohol, amphetamines, benzodiazepines, barbiturates, cocaine, marijuana, opiates, etc.) in urine (iCup) Pregnancy based on urine test. The safety of MR systems has not been established for fetuses Having electrically, magnetically, or mechanically activated implants (e.g., cardiac pacemakers), because the electromagnetic fields produced by the MR system may interfere with the operation of these devices.

Sites / Locations

  • Leon CountyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

With PTSD for study

Health controls for study

Arm Description

80 patients with PTSD in randomized, double-blind, controlled design

80 healthy subjects in randomized, double-blind, controlled design

Outcomes

Primary Outcome Measures

Neural response in the SPA circuitry
Spontaneous and Expt. 1b task-induced activity in the SPA circuitry (i.e., sensory cortex, prefrontal cortex, and amygdala), measured with EEG and fMRI. Measure Alpha power change
Neural response in the SPA circuitry
Spontaneous and Expt. 1b task-induced activity in the SPA circuitry (i.e., sensory cortex, prefrontal cortex, and amygdala), measured with EEG and fMRI. Measure BOLD signal change

Secondary Outcome Measures

Salience detection and vigilance behavior
In Expt. 1b., Measure Oddball detection accuracy, (%)
Salience detection and vigilance behavior
In Expt. 1b., Measure Reaction time, (ms)
Salience detection and vigilance behavior
In Expt. 1b., Measure Skin conductance response/level, (µS)

Full Information

First Posted
April 21, 2023
Last Updated
October 13, 2023
Sponsor
Florida State University
search

1. Study Identification

Unique Protocol Identification Number
NCT05895006
Brief Title
A Neurosensory Account
Official Title
A Neurosensory Account of PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
October 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The goal of this study is to develop and test a novel pathophysiology of PTSD by integrating sensory cortical (SC) and amygdala-PFC dysfunctions into a tripartite Sensory-Prefrontal-Cortex-Amygdala (SPA) model.
Detailed Description
This study includes Expt. 1a & Expt. 1b to address Aims 1& 2--intrinsic and novelty-related SC disinhibition and SPA pathology in PTSD. The investigators will recruit 80 healthy subjects and 80 patients with PTS randomized, double-blind, controlled design, where tACS will be delivered at individual alpha peak frequency (active condition) and random frequency (1-200 Hz; random noise stimulation/RNS; active control condition), randomly assigned across subjects in each group. Simultaneous EEG- fMRI recordings during the resting state (Expt. 1a) and during the novelty task (Expt. 1b) will be acquired before and after tACS/RNS. During tACS/RNS, stimulation electrodes will be placed inside the holders of the BrainProducts EEG cap attached to the head of the participant. A very weak (completely tolerable and often unnoticeable) electrical current will be applied to the scalp via the stimulation electrodes. Overall, this study will take a basic neuroscience approach to investigate pathological mechanisms underlying PTSD

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
With PTSD for study
Arm Type
Experimental
Arm Description
80 patients with PTSD in randomized, double-blind, controlled design
Arm Title
Health controls for study
Arm Type
Active Comparator
Arm Description
80 healthy subjects in randomized, double-blind, controlled design
Intervention Type
Device
Intervention Name(s)
alpha-frequency tACS
Intervention Description
The investigators will apply a 2 mA sinusoidal current oscillating at individual participants' baseline peak alpha frequencies (PAF; 7-13 Hz), which will be determined by a 3-min resting state EEG recording during the setup.
Intervention Type
Device
Intervention Name(s)
Random noise stimulation
Intervention Description
The investigators will apply a 2 mA sinusoid current oscillating at random frequency (1-200 Hz).
Primary Outcome Measure Information:
Title
Neural response in the SPA circuitry
Description
Spontaneous and Expt. 1b task-induced activity in the SPA circuitry (i.e., sensory cortex, prefrontal cortex, and amygdala), measured with EEG and fMRI. Measure Alpha power change
Time Frame
Change from Baseline/Pre- to immediately post-tACS
Title
Neural response in the SPA circuitry
Description
Spontaneous and Expt. 1b task-induced activity in the SPA circuitry (i.e., sensory cortex, prefrontal cortex, and amygdala), measured with EEG and fMRI. Measure BOLD signal change
Time Frame
Change from Baseline/Pre- to immediately post-tACS
Secondary Outcome Measure Information:
Title
Salience detection and vigilance behavior
Description
In Expt. 1b., Measure Oddball detection accuracy, (%)
Time Frame
Change from Baseline/Pre- to immediately post-tACS
Title
Salience detection and vigilance behavior
Description
In Expt. 1b., Measure Reaction time, (ms)
Time Frame
Change from Baseline/Pre- to immediately post-tACS
Title
Salience detection and vigilance behavior
Description
In Expt. 1b., Measure Skin conductance response/level, (µS)
Time Frame
Change from Baseline/Pre- to immediately post-tACS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Right-handed With normal or corrected-to-normal vision and normal olfaction Between the ages of 18 and 50 years Meeting the tACS screening criteria (see List I below; e.g., lack of a serious head injury or loss of consciousness) Patients: Diagnosis of PTSD Patients: If taking psychotropic medications, medication stability in the past 2 months If having mild substance use disorder (for patients) or occasional substance use, abstention from use 48 hours before the experiment. Exclusion Criteria: A history of diagnosis for a major medical illness (e.g., cancer, metabolic syndrome, cardiovascular disease, inflammatory disorders) or a neurological disorder (e.g., seizure, stroke, Parkinson's disease). Patients: Concurrent Axis I diagnosis (depression, anxiety, and mild substance use disorder are allowed given their high comorbidity with PTSD). Healthy controls: A history of diagnosis for a DSM-5 Axis I disorder or current use of psychoactive medications. Severe psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal, or any behavior that poses an immediate danger to self or others. History of head trauma with unconsciousness (> 5 minutes) Report that they regularly drink 3 or more alcoholic beverages a day. Report that they are unable to abstain from substance use (including alcohol, nicotine, cannabis, amphetamines, narcotics, solvents, cocaine, hallucinogens, tranquilizers, barbiturates, etc.) or sleep medication for 48 hours before being scanned. Are on calcium channel blockers (e.g., verapamil, nifedipine) or alpha-blockers (e.g., prazosin, terazosin) and are unable to stop these medications for a 48-hour period prior to scanning (to exclude the impact of these medications on the interpretation of fMRI/EEG). Failed Urine Drug Screening Test: A rapid urine screening test that utilizes monoclonal antibodies to detect elevated levels of specific drugs (including alcohol, amphetamines, benzodiazepines, barbiturates, cocaine, marijuana, opiates, etc.) in urine (iCup) Pregnancy based on urine test. The safety of MR systems has not been established for fetuses Having electrically, magnetically, or mechanically activated implants (e.g., cardiac pacemakers), because the electromagnetic fields produced by the MR system may interfere with the operation of these devices.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen Li, PhD
Phone
850-645-1409
Email
wenli@psy.fsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Li, PhD
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leon County
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Li, PhD
Phone
850-645-1409
Email
wenli@psy.fsu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication.
IPD Sharing Time Frame
Starting 6 months after publication.
IPD Sharing Access Criteria
All researchers.
IPD Sharing URL
https://clinicaltrials.gov/

Learn more about this trial

A Neurosensory Account

We'll reach out to this number within 24 hrs