Research on the Effects of Combined Neurostimulation Protocols on Stress

November 29, 2021 updated by: University Ghent

The Effects of Preconditioning Theta Burst Stimulation With Transcranial Direct Current Stimulation on Stress Regulation in Healthy Controls: a Double-blind Sham-controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: active tDCS + active iTBS
Participants will receive 20 minutes of active tDCS, during the last 7 minutes active iTBS will be applied.
Device: active tDCS
A current of 2 milliampère (mA) through electrodes of 5x5cm.
Other Names:
  • active/anodal transcranial direct current stimulation
Device: iTBS
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.
Other Names:
  • intermittent theta burst stimulation
SHAM_COMPARATOR: sham tDCS + active iTBS
Participants will receive 20 minutes of sham tDCS, during the last 7 minutes active iTBS will be applied.
Device: iTBS
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.
Other Names:
  • intermittent theta burst stimulation
Device: sham tDCS
Similar set-up as in the active tDCS, but stimulation is too short to cause any effects.
Other Names:
  • sham transcranial direct current stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in heart rate variability (HRV)
Time Frame: Through study completion, an average of two weeks
Variability in time between two heartbeats
Through study completion, an average of two weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Collaborators

University Hospital, Ghent

Investigators

  • Principal Investigator: Chris Baeken, MD, PhD, Ghent University, University Hospital Ghent
  • Principal Investigator: Marie-Anne Vanderhasselt, PhD, Ghent University, University Hospital Ghent
  • Principal Investigator: Stefaan Van Damme, PhD, University Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 29, 2018

Primary Completion (ACTUAL)

October 31, 2020

Study Completion (ACTUAL)

October 31, 2020

Study Registration Dates

First Submitted

October 2, 2018

First Submitted That Met QC Criteria

October 25, 2018

First Posted (ACTUAL)

October 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 30, 2021

Last Update Submitted That Met QC Criteria

November 29, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC/2018/0866

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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