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NCT Number: NCT07449338

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahlgrenska University Hospital, Gothenburg, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 6 weeks

    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

Secondary outcomes

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

    Time frame: 2 weeks

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

    Time frame: 12 weeks

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

    Time frame: 6 months

    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

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

    Time frame: 12 weeks

    The Sheehan Disability Scale (SDS) is a self-rating assessment (0-30 points), where a higher score indicates more pronounced functional impairment

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

    Time frame: 6 months

    The Sheehan Disability Scale (SDS) is a self-rating assessment (0-30 points), where a higher score indicates more pronounced functional impairment

  6. Difference in EQ-VAS from baseline to after last iTBS treatment

    Time frame: 2 weeks

    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

  7. Difference in EQ-VAS from baseline to six weeks after first iTBS treatment

    Time frame: 6 weeks

    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

  8. Difference in EQ-VAS from baseline to twelve weeks after first iTBS treatment

    Time frame: 12 weeks

    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

  9. Difference in EQ-VAS from baseline to six months after first iTBS treatment

    Time frame: 6 months

    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

  10. Difference in reported potential side effects from baseline to after last iTBS treatment

    Time frame: 2 weeks

    A patient-reported form including the most commonly reported side effects of rTMS.

  11. Difference in reported potential side effects from baseline to six weeks after first iTBS treatment

    Time frame: 6 weeks

    A patient-reported form including the most commonly reported side effects of rTMS.

  12. Difference in reported potential side effects from baseline to twelve weeks after first iTBS treatment

    Time frame: 12 weeks

    A patient-reported form including the most commonly reported side effects of rTMS.

  13. Difference in reported potential side effects from baseline to six months after first iTBS treatment

    Time frame: 6 months

    A patient-reported form including the most commonly reported side effects of rTMS.

  14. rTMS associated pain experience

    Time frame: 2 weeks

    A patient-reported form rating experience of pain (scale 1 to 10) during rTMS treatment. Performed after last treatment series

  15. Number of patients in remission after last iTBS treatment

    Time frame: 2 weeks

    A patient with a MADRS-S score of < 10 is considered to be in remission

  16. Number of patients in remission six weeks after first iTBS treatment

    Time frame: 6 weeks

    A patient with a MADRS-S score of < 10 is considered to be in remission

  17. Number of patients in remission twelve weeks after first iTBS treatment

    Time frame: 12 weeks

    A patient with a MADRS-S score of < 10 is considered to be in remission

  18. Number of patients in remission six months after first iTBS treatment

    Time frame: 6 months

    A patient with a MADRS-S score of < 10 is considered to be in remission

Study contacts

Contact information is provided by the study sponsor or research team.

Melker Hagsäter, MD, MSc, PhD, PhD

CONTACT

[email protected]

+46 3039 8000

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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