SMA Targeted Magnetic Stimulation Against Auditory Verbal Hallucinations (SMA-AVH)

Uppsala University

Status: Terminated

Conditions: Auditory Hallucination

Treatments: Device: continuous theta burst stimulation over the SMA; Device: sham continuous theta burst stimulation over the SMA

Study type: Interventional

Funder types: Other

Identifiers

NCT04651621

SMA-AVH

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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46 participants in 3 patient groups

Open label active cTBS

Experimental group

Description:

Four consecutive days with 40s cTBS, 100% MT over the SMA, five times a day with 50 minutes between stimulations

Treatment:

Device: continuous theta burst stimulation over the SMA

active cTBS

Experimental group

Description:

One test session with 40s active cTBS, 100% MT, over the SMA in the initial double blind cross-over phase

Treatment:

Device: continuous theta burst stimulation over the SMA

Sham cTBS

Sham Comparator group

Description:

One test session with 40s sham cTBS, 100% MT, over the SMA in the initial double blind cross-over phase with a special sham coil that diverts the magnetic field to be only superficial

Treatment:

Device: sham continuous theta burst stimulation over the SMA