Research on the Effects of Combined Neurostimulation Protocols on Stress

University Ghent

Status: Completed

Conditions: Major Depressive Disorder; Stress Related Disorder; Stress Reaction

Treatments: Device: iTBS; Device: sham tDCS; Device: active tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT03722095

EC/2018/0866

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

74 participants in 2 patient groups

active tDCS + active iTBS

Active Comparator group

Description:

Participants will receive 20 minutes of active tDCS, during the last 7 minutes active iTBS will be applied.

Treatment:

Device: active tDCS

Device: iTBS

sham tDCS + active iTBS

Sham Comparator group

Description:

Participants will receive 20 minutes of sham tDCS, during the last 7 minutes active iTBS will be applied.

Treatment:

Device: sham tDCS

Device: iTBS