Treatment of Auditory Hallucinations in Schizophrenia With Bilateral Theta Burst Stimulation

NCT02670291 | Completed DMC

• 1 other identifier: PL 525/4-1
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, sham-controlled, double blind, multicentre clinical trial aims at providing evidence for the efficacy and safety of continuous theta burst stimulation (cTBS) in the treatment of auditory hallucinations in patients with schizophrenia. Overall, the study will include 137 patients. Because of the adaptive study design, an interim analysis was performed after half of the originally planned patients (43/86), according to which the sample size was increased by 51 patients). Each patient will receive a three weeks course of daily (5/week) treatment; 50% of the patients will be treated with cTBS (1200 impulses daily), the other half with a sham stimulation to the left and right temporoparietal cortex. Sham stimulation will be applied by an active sham-coil that allows for a double-blind treatment. Follow-up assessments 1, 3 and 6 months after treatment will investigate the stability of treatment effects.

Conditions

Auditory Hallucinations; Schizophrenia

Keywords

auditory hallucinations; schizophrenia; cTBS; noninvasive brain stimulation

Outcome Measures

Primary Outcomes (1)

• Change of Psychotic Symptom Rating Scales - Auditory Hallucinations subscale (PSYRATS-AH)

  Group comparison (active vs. sham cTBS) regarding the change of the auditory hallucination subscale of the Psychotic Symptom Rating Scales (PSYRATS-AH) score from baseline to end of treatment period.

  3 weeks

Study Arms (2)

active cTBS

ACTIVE COMPARATOR

Determination of resting motor threshold (RMT); Coil position: temporoparietal cortices halfway between T3/P3 and T4/P4 (EEG 10/20 system); active cTBS (80% of RMT);

Device: MagPro Cool-B65A/P, Magventure

Sham cTBS

SHAM COMPARATOR

Determination of resting motor threshold (RMT); Coil position: temporoparietal cortices halfway between T3/P3 and T4/P4 (EEG 10/20 system); sham cTBS;

Device: MagPro Cool-B65A/P, Magventure

Interventions

MagPro Cool-B65A/P, Magventure DEVICE

combined active and sham coil

active cTBS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, age 18-65 years
• Schizophrenia (DSM-5 295.90), schizophreniform disorder (DSM-5, 295.40), or schizoaffective disorder (DSM-5 295.70)
• Auditory hallucinations (AH) present at least once a week, for at least 3 months
• No sufficient effect of at least one adequate antipsychotic treatment
• Severity according to PANSS hallucination score (Item P3) of 3 or more
• Fluent German language
• Stable antipsychotic medication 2 weeks before and 3 weeks during the treatment

You may not qualify if:

• Suicidality
• History/evidence of brain surgery
• Significant brain malformation or neoplasm
• Head injury
• Cerebral vascular events
• Neurodegenerative disorder
• Deep brain stimulation
• Intracranial metallic particles
• History of seizures
• Diagnose of substance dependence or abuse as primary clinical problem
• Severe somatic comorbidity
• Cardiac pacemakers
• Pregnancy

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• German Research Foundation: collaborator
• Institute for Clinical Epidemiology and Applied Biometry, University Tuebingen, Germany: collaborator
• Center for Clinical Studies, University Tuebingen (ZKS), Germany: collaborator
• Department of Psychiatry and Psychotherapy, University Munich (LMU), Germany: collaborator
• University of Ulm: collaborator
• Department of Psychiatry and Psychotherapy; University Heidelberg, Germany: collaborator
• Department of Psychiatry and Psychotherapy; Unversity Augsburg, Germany: collaborator
• Department of Psychiatry and Psychotherapy, LVR Duesseldorf, Germany: collaborator

Study Sites (1)

Department of Psychiatry and Psychotherapy

Tübingen, 72076, Germany

Location

Related Publications (2)

• Plewnia C, Brendel B, Schwippel T, Becker-Sadzio J, Hajiyev I, Pross B, Strube W, Hasan A, Campana M, Padberg F, Mayer P, Kujovic M, Lorenz S, Schonfeldt-Lecuona C, Otte ML, Wolf RC, Hoppner-Buchmann J, Serna-Higuita LM, Martus P, Fallgatter AJ. Theta burst stimulation of temporo-parietal cortex regions for the treatment of persistent auditory hallucinations: a multicentre, randomised, sham-controlled, triple-blind phase 3 trial in Germany. Lancet Psychiatry. 2025 Sep;12(9):638-649. doi: 10.1016/S2215-0366(25)00202-0. Epub 2025 Aug 4.

  PMID: 40774272 DERIVED

• Plewnia C, Brendel B, Schwippel T, Martus P, Cordes J, Hasan A, Fallgatter AJ. Treatment of auditory hallucinations with bilateral theta burst stimulation (cTBS): protocol of a randomized, double-blind, placebo-controlled, multicenter trial. Eur Arch Psychiatry Clin Neurosci. 2018 Oct;268(7):663-673. doi: 10.1007/s00406-017-0861-3. Epub 2017 Dec 9.

  PMID: 29224040 DERIVED

MeSH Terms

Conditions

Hallucinations; Schizophrenia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Christian Plewnia, Prof. MD.

  Dept. Psychiatry and Psychotherapy, Universtiy of Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: February 1, 2016
• Study Start: January 1, 2017
• Primary Completion: November 1, 2023
• Study Completion: March 1, 2024
• Last Updated: March 25, 2024

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)