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Research on the Effects of Combined Neurostimulation Protocols on Stress

Primary Purpose

Stress Reaction, Stress Related Disorder, Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
active tDCS
sham tDCS
iTBS
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stress Reaction focused on measuring Non-invasive Brain Stimulation, intermittent Theta Burst Stimulation (iTBS), Transcranial Direct Current Stimulation (tDCS), Dorsolateral Prefrontal Cortex, Stress reactivity, Stress-related Disorders, Major Depressive Disorder

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- Aged between 18-45 years old

Exclusion Criteria:

  • The presence of psychiatric disorders
  • Usage of psychotropic medication
  • Any or cardiovascular neurological condition
  • Personal or family history of epilepsy or other neurological disorders
  • Unstable medical condition, as well as chronic pain conditions, (such as fibromyalgia) or increased blood pressure
  • Eye disease(s)
  • Current substance abuse
  • Inner ear prosthesis
  • Any implanted electronic device susceptible for magnetic field radiation (e.g. pacemaker)
  • Any implanted metal device in the head region
  • Metal objects or magnetic objects in the brain or around the head (only removable earrings & piercing are allowed)
  • Recent neurosurgical interventions
  • Pregnancy
  • Skin problems in the head region
  • Recent fractures or wounds on the hand

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

active tDCS + active iTBS

sham tDCS + active iTBS

Arm Description

Participants will receive 20 minutes of active tDCS, during the last 7 minutes active iTBS will be applied.

Participants will receive 20 minutes of sham tDCS, during the last 7 minutes active iTBS will be applied.

Outcomes

Primary Outcome Measures

Changes in heart rate variability (HRV)
Variability in time between two heartbeats

Secondary Outcome Measures

Changes in heart rate (HR)
Beats per minute
Changes in blood pressure (BP)
Both systolic and diastolic blood pressure (SBP/DBP)
Changes in electrodermal activity (EDA)
Peak amplitudes of Skin Conductive Responses (SCRs)
Changes in state-dependent mood
Visual analogue scales (VAS): total scores will be reported (range 0 to 10) with higher scores indicating worse outcome
Changes in state-dependent ruminative thinking
Brief State Rumination Inventory (BSRI): total scores will be reported (range 0 to 80) with higher scores indicating worse outcome
Changes in anxiety features - self-report
State/Trait Anxiety Inventory (STAI): total scores will be reported (range 0 to 160) with higher scores indicating worse outcome

Full Information

First Posted
October 2, 2018
Last Updated
November 29, 2021
Sponsor
University Ghent
Collaborators
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT03722095
Brief Title
Research on the Effects of Combined Neurostimulation Protocols on Stress
Official Title
The Effects of Preconditioning Theta Burst Stimulation With Transcranial Direct Current Stimulation on Stress Regulation in Healthy Controls: a Double-blind Sham-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
University Hospital, Ghent

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 study examines the effects of the combined use of two different non-invasive brain stimulation (NIBS) techniques targeting the DLPFC on stress reactivity and recovery.
Detailed Description
Transcranial Direct Current Stimulation (tDCS) will be combined with intermittent Theta Burst Stimulation (iTBS) in order to maximize the effects coming from each of the techniques on their own. A group of 74 healthy participants wil be submitted to two different stimulation protocols (sham tDCS + active iTBS and active tDCS + active iTBS) with one-week in between and results on stress reactivity will be examined. In order to improve therapeutic protocols, this study with healthy participants is a crucial first step in order to further conduct clinical studies with psychiatric samples.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Reaction, Stress Related Disorder, Major Depressive Disorder
Keywords
Non-invasive Brain Stimulation, intermittent Theta Burst Stimulation (iTBS), Transcranial Direct Current Stimulation (tDCS), Dorsolateral Prefrontal Cortex, Stress reactivity, Stress-related Disorders, Major Depressive Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active tDCS + active iTBS
Arm Type
Active Comparator
Arm Description
Participants will receive 20 minutes of active tDCS, during the last 7 minutes active iTBS will be applied.
Arm Title
sham tDCS + active iTBS
Arm Type
Sham Comparator
Arm Description
Participants will receive 20 minutes of sham tDCS, during the last 7 minutes active iTBS will be applied.
Intervention Type
Device
Intervention Name(s)
active tDCS
Other Intervention Name(s)
active/anodal transcranial direct current stimulation
Intervention Description
A current of 2 milliampère (mA) through electrodes of 5x5cm.
Intervention Type
Device
Intervention Name(s)
sham tDCS
Other Intervention Name(s)
sham transcranial direct current stimulation
Intervention Description
Similar set-up as in the active tDCS, but stimulation is too short to cause any effects.
Intervention Type
Device
Intervention Name(s)
iTBS
Other Intervention Name(s)
intermittent theta burst stimulation
Intervention Description
54 cycles with 10 bursts of 3 pulses, train duration of 2 seconds and intertrain intervals of 6 seconds, results in 1620 pulses at 110% resting motor threshold.
Primary Outcome Measure Information:
Title
Changes in heart rate variability (HRV)
Description
Variability in time between two heartbeats
Time Frame
Through study completion, an average of two weeks
Secondary Outcome Measure Information:
Title
Changes in heart rate (HR)
Description
Beats per minute
Time Frame
Through study completion, an average of two weeks
Title
Changes in blood pressure (BP)
Description
Both systolic and diastolic blood pressure (SBP/DBP)
Time Frame
Through study completion, an average of two weeks
Title
Changes in electrodermal activity (EDA)
Description
Peak amplitudes of Skin Conductive Responses (SCRs)
Time Frame
Through study completion, an average of two weeks
Title
Changes in state-dependent mood
Description
Visual analogue scales (VAS): total scores will be reported (range 0 to 10) with higher scores indicating worse outcome
Time Frame
Through study completion, an average of two weeks
Title
Changes in state-dependent ruminative thinking
Description
Brief State Rumination Inventory (BSRI): total scores will be reported (range 0 to 80) with higher scores indicating worse outcome
Time Frame
Through study completion, an average of two weeks
Title
Changes in anxiety features - self-report
Description
State/Trait Anxiety Inventory (STAI): total scores will be reported (range 0 to 160) with higher scores indicating worse outcome
Time Frame
Through study completion, an average of two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Aged between 18-45 years old Exclusion Criteria: The presence of psychiatric disorders Usage of psychotropic medication Any or cardiovascular neurological condition Personal or family history of epilepsy or other neurological disorders Unstable medical condition, as well as chronic pain conditions, (such as fibromyalgia) or increased blood pressure Eye disease(s) Current substance abuse Inner ear prosthesis Any implanted electronic device susceptible for magnetic field radiation (e.g. pacemaker) Any implanted metal device in the head region Metal objects or magnetic objects in the brain or around the head (only removable earrings & piercing are allowed) Recent neurosurgical interventions Pregnancy Skin problems in the head region Recent fractures or wounds on the hand
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Baeken, MD, PhD
Organizational Affiliation
Ghent University, University Hospital Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marie-Anne Vanderhasselt, PhD
Organizational Affiliation
Ghent University, University Hospital Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefaan Van Damme, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made public on the open science framework website.
IPD Sharing Time Frame
After study completion.
IPD Sharing Access Criteria
Open acces
IPD Sharing URL
https://osf.io

Learn more about this trial

Research on the Effects of Combined Neurostimulation Protocols on Stress

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