Theta Burst Transcranial Magnetic Stimulation as Treatment for Auditory Verbal Hallucinations

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by UMC Utrecht
Sponsor:
Information provided by (Responsible Party):
Iris Sommer, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01512290
First received: January 9, 2012
Last updated: January 9, 2013
Last verified: January 2013
  Purpose

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 Intervention
Schizophrenia
Psychotic Disorders
Other: Theta Burst Transcranial Magnetic Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Theta Burst Transcranial Magnetic Stimulation as Treatment for Auditory Verbal Hallucinations; a Placebo-controlled Trail

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Change in severity and frequency of auditory verbal hallucinations [ Time Frame: 1 week/ 1 month ] [ Designated as safety issue: No ]
    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:
  • Number and severity of adverse events [ Time Frame: 1 week/ 1 month ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512290

Contacts
Contact: Anne Lotte Meijering, MSc +31887559046 A.L.Meijering@hotmail.nl
Contact: Iris Sommer, Prof, dr. +3188755370 I.Sommer@umcutrecht.nl

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

No publications provided

Responsible Party: Iris Sommer, Principle Investigator, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01512290     History of Changes
Other Study ID Numbers: UMCU_TBS
Study First Received: January 9, 2012
Last Updated: January 9, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
Auditory verbal hallucinations
Transcranial Magnetic stimulation
Theta Burst frequency

Additional relevant MeSH terms:
Hallucinations
Psychotic Disorders
Mental Disorders
Schizophrenia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on July 20, 2014