Back to resultsNon-invasive Brain Stimulation for the Treatment of Psychiatric Disorders
Primary Purpose
Mental Disorders
Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
transcranial Direct Current Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Mental Disorders
Eligibility Criteria
Inclusion Criteria:
- a psychiatric disorder in which available treatment are either ineffective or not tolerated
Exclusion Criteria:
- implantable active devices
Sites / Locations
- AOU "Federico II" of NaplesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
transcranial Direct Current Stimulation
Arm Description
daily or twice-a-day administration of transcranial Direct Current Stimulation
Outcomes
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01872143
Brief Title
Non-invasive Brain Stimulation for the Treatment of Psychiatric Disorders
Official Title
Non-invasive Brain Stimulation for the Treatment of Psychiatric Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
transcranial Direct Current Stimulation
Arm Type
Experimental
Arm Description
daily or twice-a-day administration of transcranial Direct Current Stimulation
Intervention Type
Device
Intervention Name(s)
transcranial Direct Current Stimulation
Intervention Description
daily or twice-a-day administration of transcranial Direct Current Stimulation from a minimum of 10 session to a maximum of 20
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
a psychiatric disorder in which available treatment are either ineffective or not tolerated
Exclusion Criteria:
implantable active devices
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
giordano d'urso, MD, PhD
Phone
+390817462652
Email
giordanodurso@me.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
giordano d'urso, MD, PhD
Organizational Affiliation
AOU "Federico II" of Naples
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOU "Federico II" of Naples
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
d'urso
Email
giordanodurso@me.com
First Name & Middle Initial & Last Name & Degree
giordano d'urso, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Non-invasive Brain Stimulation for the Treatment of Psychiatric Disorders
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