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Trial record 41 of 49 for:    "Depressive Disorder" [DISEASE] AND Behavioral | ( Map: Belgium )

Research on the Effects of Combined Neurostimulation Protocols on Stress

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ClinicalTrials.gov Identifier: NCT03722095
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : April 25, 2019
Sponsor:
Collaborator:
University Hospital, Ghent
Information provided by (Responsible Party):
University Ghent

Brief 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.

Condition or disease Intervention/treatment Phase
Stress Reaction Stress Related Disorder Major Depressive Disorder Device: active tDCS Device: sham tDCS Device: iTBS Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: active tDCS + active iTBS
Participants will receive 20 minutes of active tDCS, during the last 7 minutes active iTBS will be applied.
Device: active tDCS
A current of 2 milliampère (mA) through electrodes of 5x5cm.
Other Name: active/anodal transcranial direct current stimulation

Device: 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.
Other Name: intermittent theta burst stimulation

Sham Comparator: sham tDCS + active iTBS
Participants will receive 20 minutes of sham tDCS, during the last 7 minutes active iTBS will be applied.
Device: sham tDCS
Similar set-up as in the active tDCS, but stimulation is too short to cause any effects.
Other Name: sham transcranial direct current stimulation

Device: 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.
Other Name: intermittent theta burst stimulation




Primary Outcome Measures :
  1. Changes in heart rate variability (HRV) [ Time Frame: Through study completion, an average of two weeks ]
    Variability in time between two heartbeats


Secondary Outcome Measures :
  1. Changes in heart rate (HR) [ Time Frame: Through study completion, an average of two weeks ]
    Beats per minute

  2. Changes in blood pressure (BP) [ Time Frame: Through study completion, an average of two weeks ]
    Both systolic and diastolic blood pressure (SBP/DBP)

  3. Changes in electrodermal activity (EDA) [ Time Frame: Through study completion, an average of two weeks ]
    Peak amplitudes of Skin Conductive Responses (SCRs)

  4. Changes in state-dependent mood [ Time Frame: Through study completion, an average of two weeks ]
    Visual analogue scales (VAS): total scores will be reported (range 0 to 10) with higher scores indicating worse outcome

  5. Changes in state-dependent ruminative thinking [ Time Frame: Through study completion, an average of two weeks ]
    Brief State Rumination Inventory (BSRI): total scores will be reported (range 0 to 80) with higher scores indicating worse outcome

  6. Changes in anxiety features - self-report [ Time Frame: Through study completion, an average of two weeks ]
    State/Trait Anxiety Inventory (STAI): total scores will be reported (range 0 to 160) with higher scores indicating worse outcome



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03722095


Contacts
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Contact: Chris Baeken, MD, PhD +3293325543 Chris.Baeken@ugent.be
Contact: Stefanie De Smet, M.Sc. Stefanie.DeSmet@UGent.be

Locations
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Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Chris Baeken         
Contact: Stefanie De Smet         
Sponsors and Collaborators
University Ghent
University Hospital, Ghent
Investigators
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Principal Investigator: 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

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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT03722095     History of Changes
Other Study ID Numbers: EC/2018/0866
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made public on the open science framework website.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: After study completion.
Access Criteria: Open acces
URL: https://osf.io

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Ghent:
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
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Behavioral Symptoms
Disease
Fractures, Stress
Pathologic Processes
Mood Disorders
Mental Disorders
Fractures, Bone
Wounds and Injuries