Effects of tDCS Combined With VR on Anxious Ruminations in Healthy Subjects With a Vulnerability to Rumination

NCT03915041 | Completed

• 1 other identifier: RC17_0390
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study proposes: to evaluate 1) whether the combination of virtual reality (VR) and active tDCS provides better rumination attenuation than the combination of VR and tDCS placebo 2) the acceptability and experiential experience of combining these two well known medical devices.

Conditions

Rumination

Keywords

virtual reality; brain stimulation; tDCS; phenomenology

Outcome Measures

Primary Outcomes (1)

• Change in anxious ruminations after anodal tDCS and virtual reality

  Change in anxious ruminations after anodal tDCS and virtual reality will be evaluated to compare the effects of tDCS associated with virtual reality versus virtual reality alone (+ tDCS placebo) to reduce ruminations. Evaluate with Brief State Ruminative Inventory (BSRI). It is a scale with 8 items. Each item is VAS with a score ranging between 0 and 100. The total score is sum of each item score (Total /800)

  within 1 week

Study Arms (2)

VR + active brain stimulation

EXPERIMENTAL

Exposure to a virtual reality world with active transcranial electric stimulation

Device: VR + active brain stimulation

VR + sham brain stimulation

SHAM COMPARATOR

Exposure to a virtual reality world with sham transcranial electric stimulation

Device: VR +sham brain stimulation

Interventions

VR + active brain stimulation DEVICE

Active Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)

VR + active brain stimulation

VR +sham brain stimulation DEVICE

Sham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)

VR + sham brain stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Without any particular ethnic and psychosocial criteria
• Subject to ruminations (personality trait) documented by a RRS-SF score \>30
• Subjects with score to BDI scal \<14 assessed during first visit
• Subjects without psychiatric or addictive disorders.
• Subjects who do not meet all the diagnostic criteria for an anxiety disorder or characterized depressive episode.

You may not qualify if:

• contraindication to tDCS (neurosurgical history, intracranial device, skin problems)
• current virtual reality intolerance
• history of psychiatric or addictive disorders
• Use of psychotropic drugs
• Use of non psychotropic treatments significantly influencing mood or level of anxiety
• pregnant or breast-feeding women
• Neurological pathology, locomotor disability, or sensory (vestibular, visual, auditory ...)

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

University Hospital

Nantes, France

Location

MeSH Terms

Conditions

Rumination Syndrome

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: April 16, 2019
• Study Start: May 15, 2019
• Primary Completion: August 14, 2020
• Study Completion: August 14, 2020
• Last Updated: August 27, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)