Clinical trial NCT04651621: SMA Targeted Magnetic Stimulation Against Auditory Verbal Hallucinations
Official title: SMA Targeted Magnetic Stimulation Against Auditory Verbal Hallucinations
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Auditory Hallucination
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: First phase is a cross-over with two randomized blinded sessions with either verum cTBS or sham with wash-out, for each participant, and a second open feasibility treatment phase with 5 sessions/day over four days for participants with distressing auditory verbal hallucinations
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Amplitude on EEG in speech-listen task
timeFrame: 5-30 minutes after intervention
measure: Change on The Psychotic Symptom Rating Scales (PSYRATS)
timeFrame: 1 day after completion of open treatment phase
Secondary outcomes:
measure: Finger tapping test
timeFrame: 5-30 minutes after intervention
measure: Double step saccade-task
timeFrame: 20-60 minutes after intervention
measure: Resting state functional magnetic resonance imaging (rsfMRI)
timeFrame: 1 day after completion of open treatment phase
measure: Magnetic resonance spectroscopy (MRS) over the SMA quantifying glutamate and gamma-aminobutyric acid (GABA) and other metabolites
timeFrame: 1 day after completion of open treatment phase
measure: Brief Psychiatric Rating Scale (BPRS)
timeFrame: 1 day after completion of open treatment phase
measure: App recorded ratings of auditory verbal hallucinations (AVH)
timeFrame: From first day of open treatment phase, and through one week after completion of treatment
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Department of neuroscience, psychiatry, unit for Brain Stimulation and psychiatric clinical trials
Study officials:
affiliation: Uppsala University
name: Robert Boden, MD
role: PRINCIPAL_INVESTIGATOR
References: