Stress ReactionNCT03722095
Research on the Effects of Combined Neurostimulation Protocols on Stress
A study testing active tDCS and iTBS in people with Stress Reaction and Stress Related Disorder, run by University Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Reaction, Stress Related Disorder, Major Depressive Disorder
- What is being tested?
- active tDCS and iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Oct 2018to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18-45 years old
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- active tDCS, sham tDCS, iTBS
- Keywords
- 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
- Medical subject headings
- Fractures, Stress, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active tDCSDevice
Also called active/anodal transcranial direct current stimulation
A current of 2 milliampère (mA) through electrodes of 5x5cm.
sham tDCSDevice
Also called sham transcranial direct current stimulation
Similar set-up as in the active tDCS, but stimulation is too short to cause any effects.
iTBSDevice
Also called intermittent theta burst stimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| active tDCS + active iTBS | Active comparator | Participants will receive 20 minutes of active tDCS, during the last 7 minutes active iTBS will be applied. Receives: Device: active tDCS; Device: iTBS |
| sham tDCS + active iTBS | Sham comparator | Participants will receive 20 minutes of sham tDCS, during the last 7 minutes active iTBS will be applied. Receives: Device: sham tDCS; Device: iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in heart rate variability (HRV)
Variability in time between two heartbeats
Measured: Through study completion, an average of two weeks
Secondary outcomes (6)
Changes in heart rate (HR)
Beats per minute
Measured: Through study completion, an average of two weeks
Changes in blood pressure (BP)
Both systolic and diastolic blood pressure (SBP/DBP)
Measured: Through study completion, an average of two weeks
Changes in electrodermal activity (EDA)
Peak amplitudes of Skin Conductive Responses (SCRs)
Measured: Through study completion, an average of two weeks
Changes in state-dependent mood
Visual analogue scales (VAS): total scores will be reported (range 0 to 10) with higher scores indicating worse outcome
Measured: Through study completion, an average of two weeks
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
Measured: Through study completion, an average of two weeks
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
Measured: Through study completion, an average of two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start29 Oct 2018
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress ReactionStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent
- Responsible party
- Sponsor
- Investigators
- Chris Baeken, MD, PhD, Principal investigator, Ghent University, University Hospital GhentMarie-Anne Vanderhasselt, PhD, Principal investigator, Ghent University, University Hospital GhentStefaan Van Damme, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722095
- Sponsor's protocol ID
- EC/2018/0866
- Status last verified
- Nov 2021
- First submitted
- 2 Oct 2018
- Last updated
- 30 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made public on the open science framework website.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03722095
- Acronym / sponsor ID
- EC/2018/0866
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University Hospital, Ghent
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active tDCS + active iTBS | Active comparator | Device: active tDCS, Device: iTBSParticipants will receive 20 minutes of active tDCS, during the last 7 minutes active iTBS will be applied. |
| sham tDCS + active iTBS | Sham comparator | Device: sham tDCS, Device: iTBSParticipants will receive 20 minutes of sham tDCS, during the last 7 minutes active iTBS will be applied. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Aged between 18-45 years old
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active tDCSAlso: active/anodal transcranial direct current stimulationA current of 2 milliampère (mA) through electrodes of 5x5cm. | Device | active tDCS + active iTBS |
| sham tDCSAlso: sham transcranial direct current stimulationSimilar set-up as in the active tDCS, but stimulation is too short to cause any effects. | Device | sham tDCS + active iTBS |
| iTBSAlso: intermittent theta burst stimulation54 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. | Device | active tDCS + active iTBS, sham tDCS + active iTBS |
Primary outcome
Changes in heart rate variability (HRV)
Time frame: Through study completion, an average of two weeks
Variability in time between two heartbeats
6 secondary outcomes
Changes in heart rate (HR)
Time frame: Through study completion, an average of two weeks
Changes in blood pressure (BP)
Time frame: Through study completion, an average of two weeks
Changes in electrodermal activity (EDA)
Time frame: Through study completion, an average of two weeks
Changes in state-dependent mood
Time frame: Through study completion, an average of two weeks
Changes in state-dependent ruminative thinking
Time frame: Through study completion, an average of two weeks
Changes in anxiety features - self-report
Time frame: Through study completion, an average of two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Individual participant dataSharing planned: Yes. Data will be made public on the open science framework website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Baeken, MD, PhD principal investigator
Ghent University, University Hospital Ghent
Marie-Anne Vanderhasselt, PhD principal investigator
Ghent University, University Hospital Ghent
Stefaan Van Damme, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active tDCS and iTBS in people with Stress Reaction and Stress Related Disorder, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in heart rate variability (HRV) (time frame: Through study completion, an average of two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.