Transcranial Brain Stimulation and Its Underlying Neural Mechanisms as a Novel Treatment for Auditory Hallucinations

NCT02769507 | Completed DMC

• 1 other identifier: UiB-BFS-01/2016
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to investigate whether transcranial direct current stimulation (tDCS) reduces auditory hallucinations in patients with psychosis. In addition, the neuronal changes of tDCS will be examined.

Conditions

Psychotic Disorders

Outcome Measures

Primary Outcomes (5)

• Auditory Hallucination Rating Scale (AHRS)

  Measure for severity of hallucinations

  Change from Baseline to immediately after treatment and 3 months after treatment

• Questionnaire for Psychotic Experiences (QPE)

  Measure for severity of hallucinations

  Change from Baseline to immediately after treatment and 3 months after treatment

• Positive and Negative Syndrome Scale (PANSS)

  Measure for positive and negative symptoms in psychotic disorders

  Change from Baseline to immediately after treatment and 3 months after treatment

• Hallucinations App

  iPhone/iPod application for self-ratings of auditory hallucinations

  Continuously between baseline and 3 months after treatment

• Hallucination Change Scale (HCS)

  Measure for changes in severity of auditory hallucinations

  Change from Baseline to immediately after treatment and 3 months after treatment

Secondary Outcomes (13)

• Stroop task

  Change from Baseline to immediately after treatment and 3 months after treatment

• Trailmaking test A and B

  Change from Baseline to immediately after treatment and 3 months after treatment

• Expectations Questionnaire

  Change from Baseline to immediately after treatment and 3 months after treatment

• Adverse Effects Questionnaire

  The questionnaire is completed after each tDCS session. That is, twice on each day of the five day treatment program

• The Clinical Global Impressions Scale - Severity

  Change from Baseline to immediately after treatment and 3 months after treatment

Study Arms (2)

real tDCS

EXPERIMENTAL

DC Stimulator PLUS (NeuroConn) The real tDCS condition comprises two daily sessions of 20 min tDCS, separated by a minimum break of 3h, for five consecutive days. Anodal and cathodal tDCS will be applied with 2mA to the left dorsolateral prefrontal cortex (a point midway between F3 and FP1) and the left peri-Sylvian region (a point midway between T3 and P3), respectively. Electrode size is 7cm x 5cm.

Device: DC Stimulator PLUS (NeuroConn)

sham tDCS

SHAM COMPARATOR

DC Stimulator PLUS (NeuroConn) The sham condition is identical to the "real tDCS" condition except that after 40s of tDCS stimulation is going to be reduced to a small pulse every 550msec (110 μA over 15 msec) through the remainder of the 20 minute period.

Device: DC Stimulator PLUS (NeuroConn)

Interventions

DC Stimulator PLUS (NeuroConn) DEVICE

real tDCS; sham tDCS

Eligibility Criteria

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

You may qualify if:

• Diagnosed with schizophrenia spectrum disorder or other psychotic disorder
• Frequent auditory hallucinations (at least 5 times a week).
• Patients are on a stable dose of antipsychotic medication (which can also be zero) for at least 2 weeks.
• Mentally competent for informed consent.
• Provided 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)
• History of seizures, or a history of seizures in first-degree relatives.
• History of eye trauma with a metal object or professional metal workers
• History of brain surgery, brain infarction, head trauma, cerebrovascular accident, broken skull, brain tumour, heart disease, cardiac pacemaker.
• Skin disease on the scalp on the position of the tDCS electrodes
• Coercive treatment based on a judicial ruling
• Pregnancy in female patients

Sponsors & Collaborators

• University of Bergen: lead
• Helse-Bergen HF: collaborator

Study Sites (1)

University of Bergen

Bergen, Hordaland, 5009, Norway

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Marco Hirnstein, PhD

  University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 11, 2016
• Study Start: July 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: August 7, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

NO (1)