Prospective Cohort Study of Response and Tolerability of Accelerated Intermittent Theta-burst Stimulation (1W-AiTBS)

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.

Study Overview

• Status: Recruiting
• Conditions: Depression
• Intervention / Treatment: Device: iTBS (intermittent theta-burst stimulation)

• Study Type: Observational
• Enrollment (Estimated): 36

Contacts and Locations

• Study Contact: Name: Melker Hagsäter, MD, MSc, PhD, PhD; Phone Number: +46 3039 8000; Email: melker.hagsater@vgregion.se

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Caroline Wass; Phone Number: +46 3039 8000; Email: caroline.wass@vgregion.se
  • Kungälv, Sweden
    • Recruiting
    • Kungälv Hospital, Kungälv
    • Contact: Melker Hagsäter; Phone Number: +46 10441 00 00; Email: melker.hagsater@vgregion.se
  • Vaxjo, Sweden
    • Recruiting
    • Central Hospital Växjö
    • Contact: Melker Hagsäter; Phone Number: +46 10441 00 00; Email: melker.hagsater@vgregion.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in SDS from baseline to six months after first iTBS treatment	The Sheehan Disability Scale (SDS) is a self-rating assessment (0-30 points), where a higher score indicates more pronounced functional impairment	6 months
Difference in EQ-VAS from baseline to six weeks after first iTBS treatment	The EQ-5D visual analogue scale (EQ-VAS) is a self-rating assessment (VAS 0-100 points), where a higher (VAS) score indicates a higher health-related quality of life	6 weeks
Difference in EQ-VAS from baseline to six months after first iTBS treatment	The EQ-5D visual analogue scale (EQ-VAS) is a self-rating assessment (VAS 0-100 points), where a higher (VAS) score indicates a higher health-related quality of life	6 months
Number of patients in remission six weeks after first iTBS treatment	A patient with a MADRS-S score of < 10 is considered to be in remission	6 weeks
Difference in MADRS-S from baseline to after last 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	2 weeks
Difference in MADRS-S from baseline to twelve 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	12 weeks
Difference in MADRS-S from baseline to six months 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 months
Difference in SDS from baseline to twelve weeks after first iTBS treatment	The Sheehan Disability Scale (SDS) is a self-rating assessment (0-30 points), where a higher score indicates more pronounced functional impairment	12 weeks
Difference in EQ-VAS from baseline to after last iTBS treatment	The EQ-5D visual analogue scale (EQ-VAS) is a self-rating assessment (VAS 0-100 points), where a higher (VAS) score indicates a higher health-related quality of life	2 weeks
Difference in EQ-VAS from baseline to twelve weeks after first iTBS treatment	The EQ-5D visual analogue scale (EQ-VAS) is a self-rating assessment (VAS 0-100 points), where a higher (VAS) score indicates a higher health-related quality of life	12 weeks
Difference in reported potential side effects from baseline to after last iTBS treatment	A patient-reported form including the most commonly reported side effects of rTMS.	2 weeks
Difference in reported potential side effects from baseline to six weeks after first iTBS treatment	A patient-reported form including the most commonly reported side effects of rTMS.	6 weeks
Difference in reported potential side effects from baseline to twelve weeks after first iTBS treatment	A patient-reported form including the most commonly reported side effects of rTMS.	12 weeks
Difference in reported potential side effects from baseline to six months after first iTBS treatment	A patient-reported form including the most commonly reported side effects of rTMS.	6 months
Number of patients in remission after last iTBS treatment	A patient with a MADRS-S score of < 10 is considered to be in remission	2 weeks
Number of patients in remission twelve weeks after first iTBS treatment	A patient with a MADRS-S score of < 10 is considered to be in remission	12 weeks
Number of patients in remission six months after first iTBS treatment	A patient with a MADRS-S score of < 10 is considered to be in remission	6 months
rTMS associated pain experience	A patient-reported form rating experience of pain (scale 1 to 10) during rTMS treatment. Performed after last treatment series	2 weeks

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: depression; rTMS; iTBS
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: 1W-AiTBS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No