Clinical trial NCT03722095: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
First posted: 2018-10-26
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Changes in heart rate variability (HRV)
timeFrame: Through study completion, an average of two weeks
Secondary outcomes:
measure: Changes in heart rate (HR)
timeFrame: Through study completion, an average of two weeks
measure: Changes in blood pressure (BP)
timeFrame: Through study completion, an average of two weeks
measure: Changes in electrodermal activity (EDA)
timeFrame: Through study completion, an average of two weeks
measure: Changes in state-dependent mood
timeFrame: Through study completion, an average of two weeks
measure: Changes in state-dependent ruminative thinking
timeFrame: Through study completion, an average of two weeks
measure: Changes in anxiety features - self-report
timeFrame: Through study completion, an average of two weeks
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: Ghent University, University Hospital Ghent
name: Chris Baeken, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ghent University, University Hospital Ghent
name: Marie-Anne Vanderhasselt, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Stefaan Van Damme, PhD
role: PRINCIPAL_INVESTIGATOR
References: