Major Depressive Disorder Clinical Trial
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
Verified date | November 2021 |
Source | University Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 74 |
Est. completion date | October 31, 2020 |
Est. primary completion date | October 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Ghent | Ghent |
Lead Sponsor | Collaborator |
---|---|
University Ghent | University Hospital, Ghent |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in heart rate variability (HRV) | Variability in time between two heartbeats | Through study completion, an average of two weeks | |
Secondary | Changes in heart rate (HR) | Beats per minute | Through study completion, an average of two weeks | |
Secondary | Changes in blood pressure (BP) | Both systolic and diastolic blood pressure (SBP/DBP) | Through study completion, an average of two weeks | |
Secondary | Changes in electrodermal activity (EDA) | Peak amplitudes of Skin Conductive Responses (SCRs) | Through study completion, an average of two weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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