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Recruiting NCT07449338

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

— Observational Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iTBS (intermittent theta-burst stimulation).
Who it may be relevant to
Registry conditions: Depression. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Difference in MADRS-S from baseline to six weeks after first iTBS treatment [Time frame: 6 weeks]
Secondary outcome measures (12)
  • Difference in MADRS-S from baseline to after last iTBS treatment [Time frame: 2 weeks]
  • Difference in MADRS-S from baseline to twelve weeks after first iTBS treatment [Time frame: 12 weeks]
  • Difference in MADRS-S from baseline to six months after first iTBS treatment [Time frame: 6 months]
  • Difference in SDS from baseline to twelve weeks after first iTBS treatment [Time frame: 12 weeks]
  • Difference in SDS from baseline to six months after first iTBS treatment [Time frame: 6 months]
  • Difference in EQ-VAS from baseline to after last iTBS treatment [Time frame: 2 weeks]
  • Difference in EQ-VAS from baseline to six weeks after first iTBS treatment [Time frame: 6 weeks]
  • Difference in EQ-VAS from baseline to twelve weeks after first iTBS treatment [Time frame: 12 weeks]
  • Difference in EQ-VAS from baseline to six months after first iTBS treatment [Time frame: 6 months]
  • Difference in reported potential side effects from baseline to after last iTBS treatment [Time frame: 2 weeks]
  • Difference in reported potential side effects from baseline to six weeks after first iTBS treatment [Time frame: 6 weeks]
  • Difference in reported potential side effects from baseline to twelve weeks after first iTBS treatment [Time frame: 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 3 centers
  • Sahlgrenska University Hospital — Gothenburg
  • Kungälv Hospital, Kungälv — Kungälv
  • Central Hospital Växjö — Vaxjo

Identifiers

NCT: NCT07449338 · 1W-AiTBS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗