Treatment of Auditory Hallucinations in Schizophrenia With Bilateral Theta Burst Stimulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2024-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Theta Burst Transcranial Magnetic Stimulation as Treatment for Auditory Verbal Hallucinations

NCT01512290

Schizophrenia Psychotic Disorders

COMPLETED NA

Treating Social Cognition With Theta Burst Stimulation: a Multicentric Study

NCT02479919

Social Cognition in Patients With Schizophrenia

UNKNOWN NA

Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation

NCT04392947

Major Depressive Disorder

COMPLETED NA

Magnetic Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia

NCT00186771

Schizophrenia

UNKNOWN PHASE4

Efficacy and Safety of Bilateral Theta Burst Stimulation for the Treatment of Auditory Hallucinations

NCT01478880

Auditory Hallucinations

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Auditory verbal hallucinations (AH), a cardinal feature of schizophrenia, are often severely distressing and increase the risk for violence and suicide. Although antipsychotic medication mostly exerts rapid beneficial effects on this symptom particularly in first-episode patients who continue on taking their medication (Sommer et al. 2012), in up to 25%-30% of all patients, such hallucinations persist (Shergill et al. 1998). The often progressive course of the disease and insufficient treatment adherence due to unwanted side effects significantly limit the treatment response. In turn, this lack of treatment efficacy also contributes to low treatment adherence which is generally associated with an unfavorable course of schizophrenia and increased relapse and readmission rate. New and effective treatments are therefore essential to reduce the massive individual burden and psychosocial costs associated with schizophrenia. Nevertheless, in the last decades, the hopes for new pharmacological treatment options have been disappointed and the pharmaceutical industry has apparently withdrawn from the development of new compounds for this disorder. Accordingly, the development of non-pharmacological approaches based on an increasing body of patho-physiological knowledge is even more needed to pave new ways for the treatment of this frequently detrimental symptom of schizophrenia.

The main objective of the present study is to provide high-level evidence for efficacy and safety of continuous theta burst stimulation (cTBS) in the treatment of auditory hallucination (AH) by this first full-size multicenter (3 centers) controlled clinical trial.

This is a double blind (actually triple blind, i.e. patient, clinical investigator, and person who will administer cTBS), randomized, sham-controlled clinical trial to test the efficacy and safety of bilateral (successively applied) daily cTBS to the temporoparietal cortex on the severity of AH. The study will be conducted in a two-armed parallel design in which 50 % of the patients will be treated with the verum stimulation and the other half of patients will receive the placebo / sham stimulation.

The cTBS protocol follows the method by Huang et al. (2005) and our pilot study (Plewnia et al. 2014a) to achieve a lasting reduction of cortical excitability. Accordingly, each stimulation train (40 s) of cTBS consists of 600 stimuli applied in bursts of 3 pulses at 50 Hz given every 200 ms (5 Hz). Stimulation intensity is standardized at 80% of the resting motor threshold (RMT) and applied successively to each hemisphere. For the first session, the order of right and left hemisphere will be determined by randomization and will alternate in each following session to preclude order effects.The RMT will be determined using EMG recordings from the left and right abductor pollicis brevis and defined as the minimal stimulation intensity needed to elicit at least 10 out of 20 motor-evoked-potentials of ≥ 50µV. RMT will be determined once, i.e. before the beginning of treatment period. The cTBS or sham treatment will be targeted both temporoparietal cortices halfway between T3/P3 and T4/P4 (EEG 10/20 system).

The treatment (active cTBS or sham cTBS) will be administered over a period of 3 consecutive weeks at each workday (Monday to Friday), resulting in a total of 15 treatment sessions. Ratings will be performed after the last treatment of each week by an independent rater. Follow-up visits are planned 1, 3 and 6 months after end of treatment phase to control for sustainability of cTBS treatment effects.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Auditory Hallucinations Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

active cTBS

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);

Group Type ACTIVE_COMPARATOR

MagPro Cool-B65A/P, Magventure

Intervention Type DEVICE

combined active and sham coil

Sham cTBS

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

Group Type SHAM_COMPARATOR

MagPro Cool-B65A/P, Magventure

Intervention Type DEVICE

combined active and sham coil

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MagPro Cool-B65A/P, Magventure

combined active and sham coil

Intervention Type DEVICE

MagPro Cool-B65A/P, Magventure

combined active and sham coil

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No