SMA Targeted Magnetic Stimulation Against Auditory Verbal Hallucinations

NCT ID: NCT04651621

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2024-02-08

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.

Conditions

Auditory Hallucination

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Open label active cTBS

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

Group Type: EXPERIMENTAL

continuous theta burst stimulation over the SMA

Intervention Type: DEVICE

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.

active cTBS

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

Group Type: EXPERIMENTAL

continuous theta burst stimulation over the SMA

Intervention Type: DEVICE

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 cTBS

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

Group Type: SHAM_COMPARATOR

sham continuous theta burst stimulation over the SMA

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Reported AVH with a minimum frequency of at least daily occurrence, with onset more than one month ago
• Stable psychopharmacological treatment past month

• Reporting no occurrences of AVH for the past year
• Stable psychopharmacological treatment past month

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Boden, MD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Department of neuroscience, psychiatry, unit for Brain Stimulation and psychiatric clinical trials

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

SMA-AVH

Identifier Type: -

Identifier Source: org_study_id