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Non-invasive Brain Stimulation for the Treatment of Psychiatric Disorders

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ClinicalTrials.gov Identifier: NCT01872143
Recruitment Status : Unknown
Verified June 2013 by giordano d'urso, Federico II University.
Recruitment status was:  Recruiting
First Posted : June 7, 2013
Last Update Posted : June 7, 2013
Sponsor:
Information provided by (Responsible Party):
giordano d'urso, Federico II University

Brief Summary:
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 or disease Intervention/treatment Phase
Mental Disorders Device: transcranial Direct Current Stimulation Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-invasive Brain Stimulation for the Treatment of Psychiatric Disorders
Study Start Date : May 2013
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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)
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: June 7, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Disease
Mental Disorders
Psychotic Disorders
Problem Behavior
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Behavioral Symptoms