Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03722095
Other study ID # EC/2018/0866
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT05537558 - Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
Terminated NCT02192099 - Open Label Extension for GLYX13-C-202, NCT01684163 Phase 2
Completed NCT03142919 - Lipopolysaccharide (LPS) Challenge in Depression Phase 2
Recruiting NCT05547035 - Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders N/A
Terminated NCT02940769 - Neurobiological Effects of Light on MDD N/A
Recruiting NCT05892744 - Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression Phase 4
Recruiting NCT05537584 - SMART Trial to Predict Anhedonia Response to Antidepressant Treatment Phase 4
Active, not recruiting NCT05061706 - Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder Phase 3
Completed NCT04479852 - A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder Phase 2
Recruiting NCT04032301 - Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans Phase 1
Recruiting NCT05527951 - Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study N/A
Completed NCT03511599 - Cycloserine rTMS Plasticity Augmentation in Depression Phase 1
Recruiting NCT04392947 - Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation N/A
Recruiting NCT05895747 - 5-HTP and Creatine for Depression R33 Phase Phase 2
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Recruiting NCT05813093 - Interleaved TMS-fMRI in Ultra-treatment Resistant Depression N/A
Recruiting NCT05135897 - The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
Enrolling by invitation NCT04509102 - Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder Early Phase 1
Recruiting NCT06026917 - Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET) Phase 4
Recruiting NCT06145594 - EMA-Guided Maintenance TMS for Depression N/A