SMA Targeted Magnetic Stimulation Against Auditory Verbal Hallucinations

Auditory Hallucination Clinical Trial

— SMA-AVH  

Official title:

SMA Targeted Magnetic Stimulation Against Auditory Verbal Hallucinations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04651621
• Other study ID #: SMA-AVH
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: May 2022
• Source: Uppsala University
• Contact: Daniel Larsson
• Phone: +46186112222
• Email: daniel.larsson[@]akademiska.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Auditory Hallucination
• Hallucinations

Intervention

Device:
• continuous theta burst stimulation over the SMA
Each cTBS session consists of bursts of three pulses delivered with a rate of 50 Hz, with bursts repeated at a rate of 5 Hz for a total duration of 40 seconds, summing up to 600 pulses, 100% of motor threshold (MT) and applied over bilateral SMA. The target is located in the anterior-posterior direction over the transition between pre-SMA and SMA proper, (cortical point where a vertical line will pass through the anterior commissure). The center of a figure-of-eight coil will be placed over the target, guided with neuronavigation equipment that utilizes the anatomical brain image from the pre-cTBS scanning session.
• sham continuous theta burst stimulation over the SMA
The same stimulation parameters but a concealed sham coil will be used with only superficial magnetic stimulation to mimic the sensation of the active stimulation

Locations

Country	Name	City	State
Sweden	Department of neuroscience, psychiatry, unit for Brain Stimulation and psychiatric clinical trials	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amplitude on EEG in speech-listen task	Neurophysiological outcome of the blinded cross-over phase	5-30 minutes after intervention
Primary	Change on The Psychotic Symptom Rating Scales (PSYRATS)	Auditory Verbal Hallucination symptom interview, total score	1 day after completion of open treatment phase
Secondary	Finger tapping test	Computerized version of the finger tapping test from The Halstead-Reitan Neuropsychological Test Battery, performance	5-30 minutes after intervention
Secondary	Double step saccade-task	Performance (Zimmermann et al Sci Rep, 2018).	20-60 minutes after intervention
Secondary	Resting state functional magnetic resonance imaging (rsfMRI)	Resting state SMA connectivity change as measured with fMRI	1 day after completion of open treatment phase
Secondary	Magnetic resonance spectroscopy (MRS) over the SMA quantifying glutamate and gamma-aminobutyric acid (GABA) and other metabolites	Prefrontal GABA and Glutamate concentration change as measured with a MEGA-PRESS magnetic resonance spectroscopy sequence following intervention.	1 day after completion of open treatment phase
Secondary	Brief Psychiatric Rating Scale (BPRS)	Total score	1 day after completion of open treatment phase
Secondary	App recorded ratings of auditory verbal hallucinations (AVH)	5 times a day randomized time points for app ratings of AVH	From first day of open treatment phase, and through one week after completion of treatment