This proposal seeks to carry out an open-label single arm study to examine the neurobehavioral changes induced by personalized, causal network mapping guided accelerated intermittent theta burst stimulation (aiTBS) in patients with treatment-resistant anxiety-related disorders.
Male/ female aged ≥ 21 years and ≤ 70 years
Diagnosis of an anxiety-related disorder as validated by the MINI (Specifically, the types of anxiety-related disorders are: generalized anxiety disorder; panic disorderl social anxiety disorder; obsessive compulsive disorder; post-traumatic stress disorder; agoraphobia; anxiety disorder due to another medical condition; other specified anxiety disorders; and unspecified anxiety disorder.)
Non-response to adequate trial (4 weeks) of at least two anxiety medication as verified by the study clinician, or psychotherapy for anxiety
BAI score of 16 or above
DSM-5 psychotic disorder
Significant personality disorder which may hinder the progress of this study
Drug or alcohol abuse or dependency (preceding 3 months)
Rapid clinical response required, e.g., high suicide risk
Single group
Individually Neuronavigated accelerated intermittent theta burst stimulation with MagPro X100
DeviceMagpro X100, Axilium Cobot, Localite Camera
Beck Anxiety Inventory (BAI)
The primary outcome will be the response rate as defined as ≥50% reduction from baseline BAI scores pre- and post-iTBS treatment. BAI is an ordinal self-report scale measuring physical and cognitive anxiety symptoms ranging from 0-63. Higher scores mean worse outcome.
Beck Depression Inventory (BDI)
Change in BDI scores pre- and post-iTBS treatment. BDI is an ordinal self-report scale measuring depressive symptoms ranging from 0-63. Higher scores mean worse outcome.
Penn State Worry Questionnaire (PSWQ)
Change in PSWQ scores pre- and post-iTBS treatment. PSWQ is an ordinal self-report scale measuring pathological worry ranging from 16-80. Scores depend on whether the item is worded positively or negatively.
Mini-Mood and Anxiety Symptom Questionnaire (Mini-MASQ)
Change in Mini-MASQ scores pre- and post-iTBS treatment. The Mini-MASQ is an orginal self-report scale measuring symptoms of anxiety and depression. Scores depend on whether the item is worded positively or negatively.
Hamilton Anxiety Rating Scale (HAM-A)
Change in HAM-A scores pre- and post-iTBS treatment. HAM-A is an ordinal clinician-rated scale measuring severity of psychic and somatic anxiety, ranging from 0-56. Higher scores mean a worse outcome.
Correlation of changes in functional connectivity with changes in BAI scores
The investigators will perform additional exploratory post-hoc analyses by analysing brain imaging changes before and after TMS treatment.
Click on the lead sponsor to view all of their trials.
National University Hospital, Singapore
Lead sponsor
National University of Singapore
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
