NCT03722095

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 26, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

October 29, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

2 years

First QC Date

October 2, 2018

Last Update Submit

November 29, 2021

Conditions

Stress ReactionStress Related DisorderMajor Depressive Disorder

Keywords

Non-invasive Brain Stimulationintermittent Theta Burst Stimulation (iTBS)Transcranial Direct Current Stimulation (tDCS)Dorsolateral Prefrontal CortexStress reactivityStress-related DisordersMajor Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Changes in heart rate variability (HRV)

    Variability in time between two heartbeats

    Through study completion, an average of two weeks

Secondary Outcomes (6)

  • Changes in heart rate (HR)

    Through study completion, an average of two weeks

  • Changes in blood pressure (BP)

    Through study completion, an average of two weeks

  • Changes in electrodermal activity (EDA)

    Through study completion, an average of two weeks

  • Changes in state-dependent mood

    Through study completion, an average of two weeks

  • Changes in state-dependent ruminative thinking

    Through study completion, an average of two weeks

  • +1 more secondary outcomes

Study Arms (2)

active tDCS + active iTBS

ACTIVE COMPARATOR

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

Device: active tDCSDevice: iTBS

sham tDCS + active iTBS

SHAM COMPARATOR

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

Device: sham tDCSDevice: iTBS

Interventions

active tDCSDEVICE

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

Also known as: active/anodal transcranial direct current stimulation
active tDCS + active iTBS
sham tDCSDEVICE

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

Also known as: sham transcranial direct current stimulation
sham tDCS + active iTBS
iTBSDEVICE

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.

Also known as: intermittent theta burst stimulation
active tDCS + active iTBSsham tDCS + active iTBS

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Aged between 18-45 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Fractures, StressDepressive Disorder, Major

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2018

First Posted

October 26, 2018

Study Start

October 29, 2018

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

November 30, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

Data will be made public on the open science framework website.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
After study completion.
Access Criteria
Open acces
More information

Locations

BE(1)