Research on the Effects of Combined Neurostimulation Protocols on Stress

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03722095
• Other study ID #: EC/2018/0866
• Status: Completed
• Phase: N/A
• Start date: October 29, 2018
• Est. completion date: October 31, 2020

Study information

• Verified date: November 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Fractures, Stress
• Major Depressive Disorder
• Stress Reaction
• Stress Related Disorder

Intervention

Device:
• active tDCS
A current of 2 milliampère (mA) through electrodes of 5x5cm.
• sham tDCS
Similar set-up as in the active tDCS, but stimulation is too short to cause any effects.
• iTBS
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.

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

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