Safety and Tolerability of Transcranial Direct Current St... | NCT01148212

Studies
Safety and Tolerability of Transcranial Direct Current Stimulation (tDCS)

NCT01148212

Sponsor

Ludwig-Maximilians - University of Munich

Status

Completed

Last Update Posted

Feb 8, 2011Estimated

Enrollment

15Actual

Phase

Not provided

Conditions

Best Comfort and Lowest Skin Irritation

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Jan 2011Actual

First Submitted Date

Jun 21, 2010

First Submission Date that Met QC Criteria

Jun 21, 2010

First Posted Date

Jun 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2011

Last Update Posted Date

Feb 8, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Testing safety and tolerability of transcranial direct current stimulation (2 mA, 20 minutes) in four different protocols:

saline-soaked sponges electrode with electrode gel tap-water-soaked sponges tap-water-soaked-sponges + sham stimulation

Outcome measures are tolerability (comfort rating questionnaire), impedances, skin elasticity

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

no neurological or psychiatric illness
written informed consent

Exclusion Criteria:

dermatologic diseases
medication with corticoids

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

15 healthy volunteers

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ulrich Palm, MD	Ludwig-Maximilian-University	Principal Investigator
Frank Padberg, MD	Ludwig-Maximilian-University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ludwig-Maximilian-University, Dept. of Psychiatry		Munich		80336	Germany