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| Name | Class |
|---|---|
| University Hospital, Ghent | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active tDCS + active iTBS | Active Comparator | Participants will receive 20 minutes of active tDCS, during the last 7 minutes active iTBS will be applied. |
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| sham tDCS + active iTBS | Sham Comparator | Participants will receive 20 minutes of sham tDCS, during the last 7 minutes active iTBS will be applied. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active tDCS | Device | A current of 2 milliampère (mA) through electrodes of 5x5cm. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in heart rate variability (HRV) | Variability in time between two heartbeats | Through study completion, an average of two weeks |
| 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) |
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Inclusion Criteria:
- Aged between 18-45 years old
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Ghent | 9000 | Belgium |
Data will be made public on the open science framework website.
After study completion.
Open acces
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| ID | Term |
|---|---|
| D015775 | Fractures, Stress |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| sham tDCS | Device | Similar set-up as in the active tDCS, but stimulation is too short to cause any effects. |
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| iTBS | Device | 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. |
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| 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 |
| D001523 |
| Mental Disorders |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |