Theta Burst Transcranial Magnetic Stimulation as Treatment for Auditory Verbal Hallucinations

Schizophrenia Clinical Trial

Official title:

Theta Burst Transcranial Magnetic Stimulation as Treatment for Auditory Verbal Hallucinations; a Placebo-controlled Trail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512290
• Other study ID #: UMCU_TBS
• Status: Completed
• Phase: N/A
• First received: January 9, 2012
• Last updated: September 24, 2014
• Start date: March 2012
• Est. completion date: May 2014

Study information

• Verified date: September 2014
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hallucinations
• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in severity and frequency of auditory verbal hallucinations	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.	1 week/ 1 month	No
Secondary	Number and severity of adverse events	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.	1 week/ 1 month	Yes