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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

Tracking Information
First Submitted Date  ICMJE October 2, 2018
First Posted Date  ICMJE October 26, 2018
Last Update Posted Date April 25, 2019
Actual Study Start Date  ICMJE October 29, 2018
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
Changes in heart rate variability (HRV) [ Time Frame: Through study completion, an average of two weeks ]
Variability in time between two heartbeats
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03722095 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
  • Changes in heart rate (HR) [ Time Frame: Through study completion, an average of two weeks ]
    Beats per minute
  • Changes in blood pressure (BP) [ Time Frame: Through study completion, an average of two weeks ]
    Both systolic and diastolic blood pressure (SBP/DBP)
  • Changes in electrodermal activity (EDA) [ Time Frame: Through study completion, an average of two weeks ]
    Peak amplitudes of Skin Conductive Responses (SCRs)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Research on the Effects of Combined Neurostimulation Protocols on Stress
Official Title  ICMJE The Effects of Preconditioning Theta Burst Stimulation With Transcranial Direct Current Stimulation on Stress Regulation in Healthy Controls: a Double-blind Sham-controlled Study
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Stress Reaction
  • Stress Related Disorder
  • Major Depressive Disorder
Intervention  ICMJE
  • Device: active tDCS
    A current of 2 milliampère (mA) through electrodes of 5x5cm.
    Other Name: active/anodal transcranial direct current stimulation
  • 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
Study Arms  ICMJE
  • Active Comparator: active tDCS + active iTBS
    Participants will receive 20 minutes of active tDCS, during the last 7 minutes active iTBS will be applied.
    Interventions:
    • Device: active tDCS
    • Device: iTBS
  • Sham Comparator: sham tDCS + active iTBS
    Participants will receive 20 minutes of sham tDCS, during the last 7 minutes active iTBS will be applied.
    Interventions:
    • Device: sham tDCS
    • Device: iTBS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 23, 2019)
74
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2018)
50
Estimated Study Completion Date  ICMJE November 1, 2019
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Chris Baeken, MD, PhD +3293325543 Chris.Baeken@ugent.be
Contact: Stefanie De Smet, M.Sc. Stefanie.DeSmet@UGent.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03722095
Other Study ID Numbers  ICMJE EC/2018/0866
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data will be made public on the open science framework website.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Analytic Code
Time Frame: After study completion.
Access Criteria: Open acces
URL: https://osf.io
Responsible Party University Ghent
Study Sponsor  ICMJE University Ghent
Collaborators  ICMJE University Hospital, Ghent
Investigators  ICMJE
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
PRS Account University Ghent
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP