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Theta Burst Transcranial Magnetic Stimulation as Treatment for Auditory Verbal Hallucinations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01512290
Recruitment Status : Completed
First Posted : January 19, 2012
Last Update Posted : September 25, 2014
Information provided by (Responsible Party):
Iris Sommer, UMC Utrecht

Brief Summary:

Auditory verbal hallucinations (AVH) are a characterising symptom of schizophrenia. In the majority of patients, these AVH respond well to antipsychotic medication. Yet, a significant minority continues to experience frequent AVH despite optimal pharmacotherapy. The number of alternative treatment options for this medication resistant group is currently low and most of them focus on coping with the hallucinations. Transcranial magnetic stimulation (TMS), in contrast, is a non-invasive technique of influencing cortical excitability. This technique has the potential to actually decrease the frequency and severity of medication resistant hallucinations.

Several previous studies have assessed efficacy of low frequency rTMS, with contradicting results. A previous large study by the investigators group could not demonstrate efficacy of low frequency rTMS. A new stimulation protocol using theta burst rTMS (TBS) could provide a more effective therapeutic option.

Objective: The present study aims to examine the efficacy of TBS on the severity of AVH. Study design: The objectives are tested in a randomized double blind placebo-controlled trail.

Study population: 60 patients with the diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder or psychosis not otherwise specified with frequent auditory verbal hallucinations will be included.

Intervention: The participant will receive either 10 TBS treatments or 10 placebo treatments consisting of 900 pulses each with a 30 minute interval on the left temporoparietal area, distributed over 5 treatment days. Stimulation will be at 80% of the motor threshold.

Main study parameters/endpoints: the main study parameter is the change in the severity of the AVH. The secondary study parameter is the number and severity of adverse events.

Condition or disease Intervention/treatment Phase
Schizophrenia Psychotic Disorders Other: Theta Burst Transcranial Magnetic Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Theta Burst Transcranial Magnetic Stimulation as Treatment for Auditory Verbal Hallucinations; a Placebo-controlled Trail
Study Start Date : March 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Theta burst treatment
patients randomized to this arm will receive 10 TBS treatments distributed over 5 days
Other: Theta Burst Transcranial Magnetic Stimulation
This rTMS paradigm consists of 5 pulses at 50Hz repeated at 5Hz for 60 seconds with a total of 900 pulses per treatment

Placebo Comparator: sham treatment Other: Theta Burst Transcranial Magnetic Stimulation
This rTMS paradigm consists of 5 pulses at 50Hz repeated at 5Hz for 60 seconds with a total of 900 pulses per treatment

Primary Outcome Measures :
  1. Change in severity and frequency of auditory verbal hallucinations [ Time Frame: 1 week/ 1 month ]
    This is as experienced by the participant. The change in score on the Auditory Hallucination Assessment Scale (AHAS; Frederick, 2000), the PSYRATS (Haddock et al., 1999) and the total score on the PANSS item 3 (Kay et al. 1987), the item concerning the severity of the hallucinations, after one week of treatment end one month after treatment will be used for this outcome.

Secondary Outcome Measures :
  1. Number and severity of adverse events [ Time Frame: 1 week/ 1 month ]
    This is measured by the use of a selection of the Global index of Safety (Prieto, Sacristan & Gomez, 2004). The scores on this questionnaire are compared between the two conditions.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychosis not otherwise specified.
  • Age 18+ years.
  • Frequent auditory verbal hallucinations (cut-off at >once an hour).
  • Written informed consent.

Exclusion Criteria:

  • Metal objects in or around the head that cannot be removed (i.e. cochlear implant, surgical clips, piercing, cardiac pacemaker, medicinal pumps)
  • History of seizures
  • Increased intracranial pressure due to infarcts or trauma.
  • History of eye trauma with a metal object or professional metal workers
  • Patients who are coercively treated at a psychiatric ward (based on a judicial ruling)
  • Patients who are represented by a legal ward or under legal custody
  • In female patients, there should be no possibility for pregnancy as determined with a pregnancy test
  • Changes in the prescribed medication in a period of 2 weeks prior to participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01512290

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UMC Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
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Study Director: Iris Sommer, Prof., Dr. UMC Utrecht
Principal Investigator: Anne Lotte Meijering, MSc. UMC Utrecht

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Responsible Party: Iris Sommer, Principle Investigator, UMC Utrecht Identifier: NCT01512290     History of Changes
Other Study ID Numbers: UMCU_TBS
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014
Keywords provided by Iris Sommer, UMC Utrecht:
Auditory verbal hallucinations
Transcranial Magnetic stimulation
Theta Burst frequency
Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms