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

NCT01478880 | Completed Phase 2

• 1 other identifier: TBS-H 1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

First clinical studies indicate an effect of repetitive transcranial magnetic stimulation(rTMS) in the treatment of auditory hallucinations (AH). However, effect size, optimal stimulation site and parameters are unclear. With this randomized, placebo-controlled clinical trial we test the efficacy and safety of bilateral continuous theta burst stimulation (cTBS), a patterned form rTMS, against auditory hallucinations. The treatment will be applied add-on to individual antipsychotic and behavioral therapy. Patients will be treated for 6 weeks each weekday (30 sessions) with 40s of cTBS (halfway between T3/P3 and T4/P4). For weeks 1-3, half of the subjects will be randomized to a sham-stimulation (coil tilted 45°). During weeks 4-6, all subjects receive real cTBS.

Conditions

Auditory Hallucinations

Outcome Measures

Primary Outcomes (1)

• Psychotic Symptom Rating Scales (PSYRATS), subscale for auditory hallucinations

  Change of PSYRATS AH score compared to baseline after 3 weeks of treatment

  3 weeks

Secondary Outcomes (3)

• Hallucination change score (HCS)

  3 and 6 weeks

• Positive and Negative Symptom Scale (PANSS)

  3 and 6 weeks

• PSYRATS subscale for auditory hallucinations

  6 weeks

Study Arms (2)

cTBS

EXPERIMENTAL

Procedure: continuous theta burst stimulation (cTBS)

Sham cTBS

SHAM COMPARATOR

Procedure: sham cTBS

Interventions

continuous theta burst stimulation (cTBS) PROCEDURE

bilateral continuous theta burst stimulation (bursts of 3 stimuli, 50Hz every 200ms for 40s, 80% active motor threshold) to the temporoparietal cortex (EEG 10/20: halfway T3/P3 and T4/P4)

cTBS

sham cTBS PROCEDURE

bilateral continuous theta burst stimulation (bursts of 3 stimuli, 50Hz every 200ms for 40s, 80% active motor threshold) to the temporoparietal cortex (EEG 10/20: halfway T3/P3 and T4/P4) with the stimulation coil tilted 45°

Sham cTBS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• auditory hallucinations at least once a week
• Schizophrenia (DSM-IV)
• stable treatment setting (in- or out-patient)
• no change of antipsychotics during and at least 1 week before treatment initiation

You may not qualify if:

• epilepsy
• benzodiazepines \> 1,5mg lorazepam / d
• pregnancy
• metal parts in the brain
• cardiac pacemaker
• deep brain stimulation

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University of Tübingen, Department of Psychiatry and Psychotherapy

Tübingen, Germany

Location

MeSH Terms

Conditions

Hallucinations

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian Plewnia, MD

  Universtity of Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2011
• First Posted: November 23, 2011
• Study Start: May 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 16, 2013

Record last verified: 2013-07

Locations

DE (1)