Theta Burst Transcranial Magnetic Stimulation as Treatment for Auditory Verbal Hallucinations

NCT01512290 | Completed DMC

• 1 other identifier: UMCU_TBS
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Psychotic Disorders

Keywords

Auditory verbal hallucinations; Transcranial Magnetic stimulation; Theta Burst frequency

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number and severity of adverse events

  1 week/ 1 month

Study Arms (2)

Theta burst treatment

ACTIVE COMPARATOR

patients randomized to this arm will receive 10 TBS treatments distributed over 5 days

Other: Theta Burst Transcranial Magnetic Stimulation

sham treatment

PLACEBO COMPARATOR

Other: Theta Burst Transcranial Magnetic Stimulation

Interventions

Theta Burst Transcranial Magnetic Stimulation OTHER

This rTMS paradigm consists of 5 pulses at 50Hz repeated at 5Hz for 60 seconds with a total of 900 pulses per treatment

Theta burst treatment; sham treatment

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

UMC Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Hallucinations

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Iris Sommer, Prof., Dr.

  UMC Utrecht

  STUDY DIRECTOR

• Anne Lotte Meijering, MSc.

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 19, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

NL (1)