Major Depressive Disorder, Stress Reaction, Stress Related Disorder
Conditions
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
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.
Interventions
DEVICEactive tDCS
A current of 2 milliampère (mA) through electrodes of 5x5cm.
DEVICEsham tDCS
Similar set-up as in the active tDCS, but stimulation is too short to cause any effects.
DEVICEiTBS
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.
Sponsors
University Hospital, Ghent
University Ghent
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in heart rate variability (HRV) | Through study completion, an average of two weeks | Variability in time between two heartbeats |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in blood pressure (BP) | Through study completion, an average of two weeks | Both systolic and diastolic blood pressure (SBP/DBP) |
| Changes in electrodermal activity (EDA) | Through study completion, an average of two weeks | Peak amplitudes of Skin Conductive Responses (SCRs) |
| Changes in heart rate (HR) | Through study completion, an average of two weeks | Beats per minute |
| 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 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 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 |
Countries
Belgium
Outcome results
None listed