VGR Accelerated TMS Treatment for Depression (VAiT)

Vastra Gotaland Region

Status: Enrolling

Conditions: Depression

Treatments: Device: iTBS (intermittent theta-burst stimulation)

Study type: Interventional

Funder types: Other

Identifiers

NCT06138678

VAiT

Details and patient eligibility

About

Intermittent theta burst stimulation (iTBS), a variant of repetitive transcranial magnetic stimulation (rTMS), is a well documented method for treatment of depression.

The aim of the study is to assess the effect of an accelerated iTBS protocol compared to a routine iTBS protocol. In the accelerated protocol patients will receive 1200 pulses per session (2 sessions per day, 15 treatment days) and in the routine protocol patients will receive 600 pulses per session (1 session per day, 30 treatment days).

Participants (n = 146) will be recruited among patients referred to iTBS and randomized to treatment. Participants will be assessed by a psychiatrist, or a resident psychiatrist, prior to treatment to assure that they fulfill all inclusion criteria and non of the exclusion criteria. A psychiatrist, or a resident psychiatrist, will assess depressive symptoms 3 and 6 weeks after first day of treatment. Patients will complete self-rating questionnaires during screening, weekly for 6 weeks starting from the first day of treatment, and 6 months after end of treatment.

Enrollment: 146 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of depression verified through a Mini International Neuropsychiatric Interview (M.I.N.I.)
• MADRS-S >= 20
• unchanged medication last month
• unchanged psychological treatment last month
• admitted to psychiatric ward last month
• no ECT or TMS last six months
• provision of signed informed consent form
• indication for TMS is depression

Exclusion criteria

• addiction (illicit drugs or alcohol)
• pregnancy
• epilepsy
• conductive ferromagnetic or other metals implanted in the head or within 30 cm of the treatment coil
• implanted device that is activated or controlled in any way by physiological signals
• implanted mediation pumps
• intracardiac lines, even when removed
• regular use of benzodiazepines
• any condition that seriously increases the risk of non-compliance or loss of follow-up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

Accelerated iTBS protocol

Experimental group

Description:

Magnetic pulses of 120% of visual motor threshold applied in triplets of 50 Hz bursts, repeated at 5 Hz; 2 seconds on and 8 seconds off; 1200 pulses per session; total duration of 6 min 40 s over the left DLPFC (F3), given in 2 sessions per day (50 min interval) on 15 week days.

Treatment:

Device: iTBS (intermittent theta-burst stimulation)

Routine iTBS protocol

Active Comparator group

Description:

Magnetic pulses of 120% of visual motor threshold applied in triplets of 50 Hz bursts, repeated at 5 Hz; 2 seconds on and 8 seconds off; 600 pulses per session; total duration of 3 min 20 s over the left DLPFC (F3), given in 1 session per day on 30 week days.

Treatment:

Device: iTBS (intermittent theta-burst stimulation)