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Transcranial Direct-current Stimulation (tDCS) in Treatment Refractory Auditory Hallucinations

NCT03485131 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2018-04-04

No results posted yet for this study

Summary

This is a 4 week therapeutic pilot study with a 4 week follow-up period involving inpatients with treatment resistant DSM-IV schizophrenia or schizoaffective disorder diagnosis. Each eligible subject will receive either 20 minutes of active tDCS (transcranial direct-current stimulation) or sham stimulation twice a day on 5 consecutive weekdays for 4 weeks with a 4 week follow-up period.

Conditions

Interventions

DEVICE

Transcranial direct-current stimulation (tDCS)

Stimulation sessions will be conducted twice a day on 5 consecutive weekdays. The twice daily sessions will be separated by at least 3 hours (one in the morning and the other one in the PM). The duration of treatment will be 4 weeks

DEVICE

Placebo

Placebo/sham stimulation: After 40 seconds of real stimulation of 2 mAmp to simulate the tDCS induced skin sensation, only a small current pulse is delivered every 550 msec (110 mAmp over 15 msec) through the remainder of the 20-minute period

Sponsors & Collaborators

  • Manhattan Psychiatric Center

    lead OTHER

Principal Investigators

  • Jean-Pierre Lindenmayer, MD · Manhattan Psychiatric Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-07-31
Completion
2018-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03485131 on ClinicalTrials.gov