Skip to main content
Clinical Trials/NCT04651621
NCT04651621
Terminated
Not Applicable

SMA Targeted Magnetic Stimulation Against Auditory Verbal Hallucinations

Uppsala University1 site in 1 country46 target enrollmentNovember 2, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Auditory Hallucination
Sponsor
Uppsala University
Enrollment
46
Locations
1
Primary Endpoint
Amplitude on EEG in speech-listen task
Status
Terminated
Last Updated
last year

Overview

Brief Summary

Auditory verbal hallucinations (AVH) are prevalent among patients with psychiatric disorders. Not only being highly stressful and functionally impairing, AVH often persist despite treatment. Recent attempts to treat AVH with add-on repetitive transcranial magnetic stimulation (rTMS) when targeting the temporoparietal junction (TPJ), a language node in the brain, has gained limited success. The aim of this investigation is to reduce AVH with rTMS using continous theta-burst stimulation over a novel target, the supplementary motor area (SMA), in participants with frequent AVH, while also assessing potential neurophysiological mechanisms underlying the symptom.

Registry
clinicaltrials.gov
Start Date
November 2, 2020
End Date
February 8, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Uppsala University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Inclusion criteria for the AVH group:
  • Reported AVH with a minimum frequency of at least daily occurrence, with onset more than one month ago
  • Stable psychopharmacological treatment past month
  • Inclusion criteria for the non-AVH control group
  • Reporting no occurrences of AVH for the past year
  • Stable psychopharmacological treatment past month
  • Inclusion criteria for the healthy control group
  • No life-time occurrence of AVH
  • No history of psychiatric disorders as assessed with a Mini-International Neuropsychiatric Interview (M.I.N.I.)

Exclusion Criteria

  • Ferromagnetic or electromagnetic implants that may pose a risk during magnetic resonance imaging (MRI) and/or cTBS
  • A history of epilepsy
  • Pregnancy
  • Current substance use disorder or a history of alcohol use disorder as assessed with Alcohol Use Disorders Identification Test (AUDIT), Drug Use Disorders Identification Test (DUDIT), urine samples with test for illicit drugs and Phosphatidylethanol (PEth)
  • Daily benzodiazepine use
  • Factors that make the participant unlikely to be able to complete the study

Outcomes

Primary Outcomes

Amplitude on EEG in speech-listen task

Time Frame: 5-30 minutes after intervention

Neurophysiological outcome of the blinded cross-over phase

Change on The Psychotic Symptom Rating Scales (PSYRATS)

Time Frame: 1 day after completion of open treatment phase

Auditory Verbal Hallucination symptom interview, total score

Secondary Outcomes

  • Double step saccade-task(20-60 minutes after intervention)
  • Finger tapping test(5-30 minutes after intervention)
  • Brief Psychiatric Rating Scale (BPRS)(1 day after completion of open treatment phase)
  • Resting state functional magnetic resonance imaging (rsfMRI)(1 day after completion of open treatment phase)
  • Magnetic resonance spectroscopy (MRS) over the SMA quantifying glutamate and gamma-aminobutyric acid (GABA) and other metabolites(1 day after completion of open treatment phase)
  • App recorded ratings of auditory verbal hallucinations (AVH)(From first day of open treatment phase, and through one week after completion of treatment)

Study Sites (1)

Loading locations...

Similar Trials