Research on the Effects of Combined Neurostimulation Protocols on Stress

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Preconditioning Theta Burst Stimulation With Transcranial Direct Current Stimulation on Stress Regulation in Healthy Controls: a Double-blind Sham-controlled Study

Conditions
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Stress Reaction, Stress Related Disorder, Major Depressive Disorder

Intervention / Treatment
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* Device: active tDCS
* Device: sham tDCS
* Device: iTBS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active tDCS + active iTBS<br>Participants will receive 20 minutes of active tDCS, during the last 7 minutes active iTBS will be applied. | Device: active tDCS<br>* A current of 2 milliampère (mA) through electrodes of 5x5cm.<br>* Other names: active/anodal transcranial direct current stimulation;Device: iTBS<br>* 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.<br>* Other names: intermittent theta burst stimulation;|
| Sham Comparator: sham tDCS + active iTBS<br>Participants will receive 20 minutes of sham tDCS, during the last 7 minutes active iTBS will be applied. | Device: sham tDCS<br>* Similar set-up as in the active tDCS, but stimulation is too short to cause any effects.<br>* Other names: sham transcranial direct current stimulation;Device: iTBS<br>* 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.<br>* Other names: intermittent theta burst stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in heart rate variability (HRV) | Variability in time between two heartbeats | Through study completion, an average of two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in heart rate (HR) | Beats per minute | Through study completion, an average of two weeks | 
| Changes in blood pressure (BP) | Both systolic and diastolic blood pressure (SBP/DBP) | Through study completion, an average of two weeks | 
| Changes in electrodermal activity (EDA) | Peak amplitudes of Skin Conductive Responses (SCRs) | Through study completion, an average of two weeks | 
| Changes in state-dependent mood | Visual analogue scales (VAS): total scores will be reported (range 0 to 10) with higher scores indicating worse outcome | Through study completion, an average of two weeks | 
| Changes in state-dependent ruminative thinking | Brief State Rumination Inventory (BSRI): total scores will be reported (range 0 to 80) with higher scores indicating worse outcome | Through study completion, an average of two weeks | 
| Changes in anxiety features - self-report | State/Trait Anxiety Inventory (STAI): total scores will be reported (range 0 to 160) with higher scores indicating worse outcome | Through study completion, an average of two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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