Skip to main content
OpenTrials
Completed

NCT Number: NCT03722095

Research on the Effects of Combined Neurostimulation Protocols on Stress

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stress Reaction Depressive Disorder Depressive Disorder, Major Fractures, Bone Fractures, Stress Major Depressive Disorder Mental Disorders Mood Disorders Stress Related Disorder Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

active tDCS

Device

A current of 2 milliampère (mA) through electrodes of 5x5cm.

Other names: active/anodal transcranial direct current stimulation

Sham tDCS

Device

Similar set-up as in the active tDCS, but stimulation is too short to cause any effects.

Other names: sham transcranial direct current stimulation

iTBS

Device

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

Primary outcomes

  1. Changes in heart rate variability (HRV)

    Time frame: Through study completion, an average of two weeks

    Variability in time between two heartbeats

Secondary outcomes

  1. Changes in heart rate (HR)

    Time frame: Through study completion, an average of two weeks

    Beats per minute

  2. Changes in blood pressure (BP)

    Time frame: Through study completion, an average of two weeks

    Both systolic and diastolic blood pressure (SBP/DBP)

  3. Changes in electrodermal activity (EDA)

    Time frame: Through study completion, an average of two weeks

    Peak amplitudes of Skin Conductive Responses (SCRs)

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • University Hospital, Ghent

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 26, 2018
Registry last updated
Nov 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.