Mechanistic Clinical Trial of Individualized tDCS for Hallucinations in Schizophrenia

NCT04248010 | Withdrawn

• 1 other identifier: 7882
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This project compares standard tDCS to individualized high-definition tDCS (HD-tDCS) for treatment of auditory verbal hallucinations in schizophrenia.

Conditions

Schizophrenia and Related Disorders

Outcome Measures

Primary Outcomes (1)

• The Auditory Hallucination Rating Scale (AHRS)

  Questionnaire-based assessment instrument for auditory verbal hallucinations, completed by study personnel.

  1 week

Study Arms (4)

standard tDCS

ACTIVE COMPARATOR

20 min of standard 2-electrode transcranial direct current stimulation (2 mA) at a previously reported scalp location.

Device: neuroConn DC-Stimulator MR

HD-tDCS - anterior target

ACTIVE COMPARATOR

20 min of individualized high-density 5-electrode transcranial direct current stimulation to anterior language areas of the brain.

Device: Soterix MxN HD-tES

HD-tDCS - posterior target

ACTIVE COMPARATOR

20 min of individualized high-density 5-electrode transcranial direct current stimulation to posterior language areas of the brain.

Device: Soterix MxN HD-tES

sham tDCS

SHAM COMPARATOR

sham transcranial direct current stimulation using a brief pulse at the beginning and end of the 20 min intervention.

Device: neuroConn DC-Stimulator MR; Device: Soterix MxN HD-tES

Interventions

neuroConn DC-Stimulator MR DEVICE

standard tDCS, active \& sham

sham tDCS; standard tDCS

Soterix MxN HD-tES DEVICE

HD-tDCS, active \& sham

HD-tDCS - anterior target; HD-tDCS - posterior target; sham tDCS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• DSM-V diagnosis of schizophrenia or schizoaffective disorder
• Capacity and willingness to provide informed consent
• Mean AHRS item score of greater or equal to 2.
• If female and not infertile, must agree to use one of the following forms of contraception for the duration of study participation: systemic hormonal treatment, an IUD which was implanted at least 2 months prior to screening, or "double-barrier" contraception. Women of child bearing potential must have a negative pregnancy test at screening
• Right handed
• Normal hearing
• Taking an antipsychotic medication at a stable dose for at least 4 weeks. All oral and depot antipsychotics are allowable.

You may not qualify if:

• Presence or positive history of unstable significant medical or neurological illness
• Substance use disorder (excluding nicotine) within last 90 days, or positive toxicology screen for any substance of abuse
• Pregnancy
• Participation in study of investigational medication/device within 4 weeks
• History of seizure, epilepsy in self or first-degree relatives, stroke, brain surgery, head injury with loss of consciousness \>1 hour or clear cognitive sequelae, intracranial metal implants, known structural brain lesion, devices that may be affected by tDCS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
• Subjects with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the 6 months prior to screening or subjects who represent a significant risk of suicide in the opinion of the investigator
• Frequent and persistent migraines
• Clinically significant skin disease
• Current use of medications known to lower seizure threshold (Lithium, Theophyline, Tricyclic antidepressants, Buproprion \>450 mg/day and Clozapine \>600 mg/day, brand name and generic methylphenidate/mixed amphetamine salts)
• History of prior clinically significant, adverse response to neurostimulation or open skin wounds that would preclude safe placement of tDCS electrodes
• Contraindication to MRI scanning, including metal implants or claustrophobia. Metal implants, pacemaker, other metal (e.g., shrapnel or surgical prostheses) or paramagnetic objects contained within the body which may present a risk to the subject or interfere with MR scan
• Medicinal patch, unless removed

Sponsors & Collaborators

• Columbia University: lead

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Active vs. sham will be masked; type of tDCS (standard or HD) will not be.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Model Details: Participants will receive one of the following: standard tDCS, HD-tDCS - anterior target, HD-tDCS - posterior target, or sham.

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 30, 2020
• Study Start: December 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share