VGR Accelerated TMS Treatment for Depression

NCT06138678 | Recruiting FDA Device

• 1 other identifier: VAiT
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Depression

Keywords

iTBS; rTMS; Depression

Outcome Measures

Primary Outcomes (1)

• Difference in MADRS-S from baseline to three weeks after first iTBS treatment

  The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms

  3 weeks

Secondary Outcomes (24)

• Difference in MADRS-S from baseline to one week after first iTBS treatment

  1 week

• Difference in MADRS-S from baseline to two weeks after first iTBS treatment

  2 weeks

• Difference in MADRS-S from baseline to four weeks after first iTBS treatment

  4 weeks

• Difference in MADRS-S from baseline to five weeks after first iTBS treatment

  5 weeks

• Difference in MADRS-S from baseline to six weeks after first iTBS treatment

  6 weeks

Study Arms (2)

Accelerated iTBS protocol

EXPERIMENTAL

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.

Device: iTBS (intermittent theta-burst stimulation)

Routine iTBS protocol

ACTIVE COMPARATOR

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.

Device: iTBS (intermittent theta-burst stimulation)

Interventions

iTBS (intermittent theta-burst stimulation) DEVICE

The iTBS treatment is a type of rTMS (repetitive transcranial magnetic stimulation), delivered with MagPro R30 stimulator and a conventional cool-B65 coil. The iTBS treatment is applied to over the dorsolateral prefrontal cortex using a standardized measuring of the anatomical landmark F3 from the 10-20 positioning system. The coil is positioned with the handle at in a 45 degree angle from the midline. The centre of the butterfly is placed towards the patient head.

Accelerated iTBS protocol; Routine iTBS protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator
• Uppsala University: collaborator
• The Swedish Society of Medicine: collaborator

Study Sites (2)

Kungälv Hospital

Kungälv, Sweden

RECRUITING

Hospital of Skövde

Skövde, Sweden

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Melker Hagsäter, MD, MSc, PhD

  Västra Götaland Regional Council

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melker Hagsäter, MD, MSc, PhD

CONTACT

+46 3039 8000; melker.hagsater@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 18, 2023
• Study Start: January 15, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)