Research on the Effects of Combined Neurostimulation Protocols on Stress

Not Applicable

Completed

• Conditions: Stress Reaction; Stress Related Disorder; Major Depressive Disorder
• Interventions: Device: active tDCS; Device: sham tDCS; Device: iTBS

• Registration Number: NCT03722095
• Lead Sponsor: University Ghent

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.

Study Timeline

• Study First Submitted: 2018-10-02
• Study First Submitted QC: 2018-10-25
• Study First Posted: 2018-10-26
• Study Start: 2018-10-29
• Primary Completion: 2020-10-31
• Study Completion: 2020-10-31
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-29
• Last Update Posted: 2021-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Changes in heart rate variability (HRV)	Through study completion, an average of two weeks	Variability in time between two heartbeats

Secondary Outcome Measures

Name	Time	Method
Changes in heart rate (HR)	Through study completion, an average of two weeks	Beats per minute
Changes in blood pressure (BP)	Through study completion, an average of two weeks	Both systolic and diastolic blood pressure (SBP/DBP)
Changes in anxiety features - self-report	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
Changes in state-dependent ruminative thinking	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
Changes in electrodermal activity (EDA)	Through study completion, an average of two weeks	Peak amplitudes of Skin Conductive Responses (SCRs)
Changes in state-dependent mood	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

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium