Olfactory and Brain Stimulations in Treatment-resistant Depression

NARecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

January 27, 2024

Primary Completion Date

January 27, 2027

Study Completion Date

October 2, 2027

Conditions
Treatment-resistant Depression
Interventions
DEVICE

Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) combined with pleasant odors delivered during the iTBS procol.

"Device: MagPro X100 (MagVenture, Mag2Health, France) iTBS protocol targeting the left dorsolateral prefrontal cortex: 50 consecutive sessions allocated on 10 days (i.e., 5 sessions per working day, 1 hour apart, for 2 weeks).~One iTBS session: burst of 3 pulses at 50 Hz repeated at 200 ms intervals for 2 s (i.e., at 5 Hz) at an intensity of 90% of rMT. A 2 s train of iTBS will be repeated every 10 s for a total of 1800 pulses per session.~Pleasant odorants will be delivered using passive diffusers placed in the room dedicated to the iTBS protocol, during the all-treatment duration. During the inclusion phase, 10 odors known to be pleasant will be presented to the subject. The 3 best rated by the subject will be chosen for olfactory stimulations. During the iTBS session, a randomly selected odor from the 3 will be presented at the same time as the iTBS treatment."

DEVICE

Non-invasive brain stimulation protocol (intermittent theta burst protocol (iTBS)) delivered alone.

"Device: MagPro X100 (MagVenture, Mag2Health, France) iTBS protocol targeting the left dorsolateral prefrontal cortex: 50 consecutive sessions allocated on 10 days (i.e., 5 sessions per working day, 1 hour apart, for 2 weeks).~One iTBS session: burst of 3 pulses at 50 Hz repeated at 200 ms intervals for 2 s (i.e., at 5 Hz) at an intensity of 90% of rMT. A 2 s train of iTBS will be repeated every 10 s for a total of 1800 pulses per session."

Trial Locations (1)

69678

RECRUITING

CH Le Vinatier, Bron

All Listed Sponsors
collaborator

Fondation de France

OTHER

lead

Hôpital le Vinatier

OTHER