Transcranial Magnetic Stimulation (TMS) for Patients With Treatment Resistant Auditory Verbal Hallucination

NCT03762746 | Unknown Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: 17-03-0206
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effect of repetitive transcranial magnetic stimulation (rTMS) in schizophrenia with treatment resistant auditory verbal hallucination

Conditions

Hallucinations, Verbal Auditory

Outcome Measures

Primary Outcomes (2)

• Hallucinations change

  Hallucinations score by Indonesia Version-Psychotic Symptom Rating Scale or PSYRATS. This auditory hallucination scale included 11 items and rated from zero to four. Symptoms over the last week will rated. The dimensions of auditory hallucinations are: frequency, duration, location, loudness, beliefs about origin, negative content, intensity of negative content, amount of distress, intensity of distress, disruption of life and control. Investigators will measure hallucination score before and after 10 session TMS. Total score consist of averaged score of dimensions. A higher score represent a worse outcome.

  2 weeks

• Source-monitoring ability

  Source-monitoring score by source monitoring task performance. Participants will ask to distinguish word between 10 silent reading and 10 covert reading and 10 new non-presented word, before TMS and after 10 session TMS. Words are current Indonesian word extract from a verbal fluency task. During the test, word will be presented during 3 seconds on a computer screen. To evaluate the source monitoring performance, investigators will consider source attribution, corresponding to number incorrect attribution for source. Score range is between 0-20 A higher total score represents a worse outcome.

  2 weeks

Secondary Outcomes (1)

• electrophysiological changes

  2 weeks

Study Arms (2)

Active

ACTIVE COMPARATOR

Intervention with transcranial magnetic stimulation (TMS) low frequency 1 Hz , 1000-pulse train, 20 minutes, 90% motor threshold in left temporo-parietal cortex for 10 consecutive days for 20 schizophrenia patients with auditory hallucination

Device: Transcranial Magnetic Stimulation

Control

SHAM COMPARATOR

Control group is received treatment as usual

Drug: Control

Interventions

Transcranial Magnetic Stimulation DEVICE

A custom TMS stimulator (MagStim) is used to generate repetitive biphasic magnetic pulses. Magnetic pulses are delivered with a figure-8-coil (Magnetic Coil Transducer). During the experiment, rTMS pulse intensity is adjusted to 90% of the motor threshold. Patients will be randomly assigned to receive a 1 Hz. The target area is stimulated for 10 consecutive days. Stimulation at 1 Hz was applied once a day for 10-days

Active

Control DRUG

The control group is receiving treatment as usual. EEG recording and psychopathological ratings are performed one day before the start and on the last day of the study

Control

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Met the criteria of all types of schizophrenia or schizoaffective based on structured clinical interview instruments for the DSM-IV axis I disorders (SCID-I)
• Patients had entered the stabilization phase with 2 to 3 months of antipsychotic treatment and no drug changes within the last 2 (two) months
• Elementary school graduated (minimum)

You may not qualify if:

• Patients with a history of stroke, heart failure, head injury, infection or brain tumor, epilepsy, alcohol and opiate abuse, amphetamines obtained from anamnesis, physical examination and patient medical records
• Patients with neurological focal deficits such as hemiparesis and cranial nerve paresis
• Patients with severe cognitive deficits (MMSE scores \<25 in the first and second graders of Senior Secondary School and \<21 in Primary School Graduates)
• Patients with severe hearing loss were assessed with a 5-word auditory test
• Patients with mental retardation, assessed using the Wechsler Test of Adult Reading (WTAR) test and data from medical records.

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital: lead

Study Sites (1)

Department of Psychiatry, Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo National Hospital Jakarta

Jakarta Pusat, DKI Jakarta, Indonesia

RECRUITING

Related Publications (3)

• Kubera KM, Barth A, Hirjak D, Thomann PA, Wolf RC. Noninvasive brain stimulation for the treatment of auditory verbal hallucinations in schizophrenia: methods, effects and challenges. Front Syst Neurosci. 2015 Oct 12;9:131. doi: 10.3389/fnsys.2015.00131. eCollection 2015.

  PMID: 26528145 BACKGROUND

• Ray P, Sinha VK, Tikka SK. Adjuvant low-frequency rTMS in treating auditory hallucinations in recent-onset schizophrenia: a randomized controlled study investigating the effect of high-frequency priming stimulation. Ann Gen Psychiatry. 2015 Feb 15;14:8. doi: 10.1186/s12991-015-0046-2. eCollection 2015.

  PMID: 25699086 BACKGROUND

• Moseley P, Fernyhough C, Ellison A. Auditory verbal hallucinations as atypical inner speech monitoring, and the potential of neurostimulation as a treatment option. Neurosci Biobehav Rev. 2013 Dec;37(10 Pt 2):2794-805. doi: 10.1016/j.neubiorev.2013.10.001. Epub 2013 Oct 12.

  PMID: 24125858 BACKGROUND

MeSH Terms

Conditions

Hallucinations

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Khamelia Malik, MD

  Department of Psychiatry, RSCM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Khamelia Malik, MD

CONTACT

+6181281296600; khameliapsi@gmail.com

Nurmiati Amir, MD

CONTACT

+6281316111953; nurmiati.a@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: We apply blinding status of trial participants, care providers, and outcome assessors. We are using TMS sham-coil with similarities in appearance, sound, heavy; also we have the timing of final unblinding of all trial participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Psychiatry Research and Development Unit

Model Details: Forty schizophrenic or schizoaffective patients with predominant audiotoric hallucinatory symptoms will be given rTMS 1 Hz intervention, 1000-pulse train, 20 min, 90% strength, 1000 pulse in left temporo-parietal cortex for 10 consecutive days (except holidays). Assessment of DN network connectivity in the brain using the results of brain wave decomposition analysis with EEGLAB. For measurement of auditor hall of hallucinations used Indonesian-Psychosis Symptom Rating Scale (INA-PSYRATS) instrument. Source monitoring capability using the INA-Source Monitoring instrument.

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: December 4, 2018
• Study Start: February 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: February 1, 2019
• Last Updated: December 4, 2018

Record last verified: 2018-11

Locations

ID (1)