Non-invasive Brain Stimulation for the Treatment of Psychiatric Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Federico II University
Sponsor:
Information provided by (Responsible Party):
giordano d'urso, Federico II University
ClinicalTrials.gov Identifier:
NCT01872143
First received: May 16, 2013
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is effective in the treatment of psychiatric disorders in which available treatments are either ineffective or not tolerated


Condition Intervention Phase
Mental Disorders
Device: transcranial Direct Current Stimulation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Non-invasive Brain Stimulation for the Treatment of Psychiatric Disorders

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • Change from Baseline Psychiatric rating scales scores at immediate post-treatment and at one-month and at three-month follow-up visits [ Time Frame: Time points: T0=baseline; T1=immediate post-treatment; T2=one-month follow-up visit; T3=3-months follow-up visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: transcranial Direct Current Stimulation
daily or twice-a-day administration of transcranial Direct Current Stimulation
Device: transcranial Direct Current Stimulation
daily or twice-a-day administration of transcranial Direct Current Stimulation from a minimum of 10 session to a maximum of 20

Detailed Description:

Depending on the specific psychiatric disorder, inhibitory or stimulating neuromodulation will be applied over the cortical region of interest, found according to the relevant scientific publication on neurophysiology of psychiatric disorders

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a psychiatric disorder in which available treatment are either ineffective or not tolerated

Exclusion Criteria:

  • implantable active devices
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01872143

Contacts
Contact: giordano d'urso, MD, PhD +390817462652 giordanodurso@me.com

Locations
Italy
AOU "Federico II" of Naples Recruiting
Naples, Italy, 80131
Contact: d'urso       giordanodurso@me.com   
Principal Investigator: giordano d'urso, MD, PhD         
Sponsors and Collaborators
Federico II University
Investigators
Principal Investigator: giordano d'urso, MD, PhD AOU "Federico II" of Naples
  More Information

No publications provided

Responsible Party: giordano d'urso, MD, PhD, Federico II University
ClinicalTrials.gov Identifier: NCT01872143     History of Changes
Other Study ID Numbers: 61/10 (Ethical Committee)
Study First Received: May 16, 2013
Last Updated: June 3, 2013
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Disease
Mental Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 23, 2014