NCT07449338

Brief Summary

Intermittent theta-burst stimulation (iTBS), a variant of repetitive transcranial magnetic stimulation (rTMS), is a well-documented treatment for depression. The aim of this study is to evaluate the effectiveness of an accelerated iTBS protocol (1W-AiTBS) in routine clinical practice. In the accelerated protocol, patients receive 600 pulses per session, for a total of 30 sessions administered over 5-14 treatment days. Patient inclusion will take place over a maximum period of 1.5 years, with a maximum sample size of 150 patients. The target sample size is at least 36 patients. Patients will complete self-rating questionnaires at screening, before and after treatment, and at 6 weeks, 12 weeks, and 6 months from the first day of treatment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress42%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

February 26, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

February 26, 2026

Last Update Submit

May 25, 2026

Conditions

Depression

Keywords

iTBSrTMSdepression

Outcome Measures

Primary Outcomes (1)

  • Difference in MADRS-S from baseline to six 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

    6 weeks

Secondary Outcomes (18)

  • Difference in MADRS-S from baseline to after last iTBS treatment

    2 weeks

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

    12 weeks

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

    6 months

  • Difference in SDS from baseline to twelve weeks after first iTBS treatment

    12 weeks

  • Difference in SDS from baseline to six months after first iTBS treatment

    6 months

  • +13 more secondary outcomes

Study Arms (1)

1W-AiTBS

Magnetic pulses of 80% 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 a maximum of 8 sessions per day (\>15 min interval), total of 30 treatments on total of 10 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.

1W-AiTBS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred for AiTBS treatment at participating study sites will be invited to participate in the study.

You may qualify if:

  • diagnosis of depression verified through a Mini International Neuropsychiatric Interview (M.I.N.I.)
  • provision of signed informed consent form
  • indication for TMS is depression

You may not qualify if:

  • 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
  • any condition that seriously increases the risk of non-compliance or loss of follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Kungälv Hospital, Kungälv

Kungälv, Sweden

RECRUITING

Central Hospital Växjö

Vaxjo, Sweden

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Central Study Contacts

Melker Hagsäter, MD, MSc, PhD, PhD

CONTACT

+46 3039 8000melker.hagsater@vgregion.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 4, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

May 28, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(3)