Research on the Effects of Combined Neurostimulation Protocols on Stress

• Sponsor: University Ghent (Other)
• Overall Status: Completed
• CT.gov ID: NCT03722095
• Collaborator: University Hospital, Ghent (Other)
• Enrollment: 74
• Location: 1
• Arms: 2
• Actual Duration (Months): 24.1
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Actual 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: Oct 29, 2018
• Actual Primary Completion Date: Oct 31, 2020
• Actual Study Completion Date: Oct 31, 2020

Arms and Interventions

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 Names: 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 Names: 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 Names: 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 Names: intermittent theta burst stimulation

Outcome Measures

Primary Outcome Measures

1. Changes in heart rate variability (HRV) [Through study completion, an average of two weeks]

   Variability in time between two heartbeats

Secondary Outcome Measures

1. Changes in heart rate (HR) [Through study completion, an average of two weeks]

   Beats per minute

2. Changes in blood pressure (BP) [Through study completion, an average of two weeks]

   Both systolic and diastolic blood pressure (SBP/DBP)

3. Changes in electrodermal activity (EDA) [Through study completion, an average of two weeks]

   Peak amplitudes of Skin Conductive Responses (SCRs)

4. Changes in state-dependent mood [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ghent	Ghent		Belgium	9000

Sponsors and Collaborators

• University Ghent
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Ghent
• ClinicalTrials.gov Identifier: NCT03722095
• Other Study ID Numbers: EC/2018/0866
• First Posted: Oct 26, 2018
• Last Update Posted: Nov 30, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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: Disease; Fractures, Stress; Depressive Disorder; Depression; Depressive Disorder, Major

Study Results

No Results Posted as of Nov 30, 2021