Research on the Effects of Combined Neurostimulation Protocols on Stress

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

Tracking Information

• First Submitted Date: October 2, 2018
• First Posted Date: October 26, 2018
• Last Update Posted Date: April 25, 2019
• Actual Study Start Date: October 29, 2018
• Estimated Primary Completion Date: November 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT03722095 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Research on the Effects of Combined Neurostimulation Protocols on Stress
• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Other

Condition

• Stress Reaction
• Stress Related Disorder
• Major Depressive Disorder

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 23, 2019): 74
• Original Estimated Enrollment (submitted: October 25, 2018): 50
• Estimated Study Completion Date: November 1, 2019
• Estimated Primary Completion Date: November 1, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Chris Baeken, MD, PhD; +3293325543; Chris.Baeken@ugent.be

Contact: Stefanie De Smet, M.Sc.; Stefanie.DeSmet@UGent.be

• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT03722095
• Other Study ID Numbers: 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

• 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: University Ghent
• Collaborators: University Hospital, Ghent

Investigators

• 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