Transcranial Direct Current Stimulation to Reduce Chronic... | NCT02048137

Studies
Transcranial Direct Current Stimulation to Reduce Chronic Pain in Patients With Chronic Inflammatory Bowel Diseases

NCT02048137

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Jan 24, 2018Actual

Enrollment

20Estimated

Phase

Phase 2

Conditions

Inflammatory Bowel Disease

Interventions

Transcranial direct current stimulation

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

ID	Type	Description	Link
EA4/135/13	Other Identifier	Charité Universitätsmedizin Berlin

Status Module

Record Verification Date

Jan 2018

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

Jan 2014

Primary Completion Date

Dec 2016Actual

Completion Date

Not provided

First Submitted Date

Jan 11, 2014

First Submission Date that Met QC Criteria

Jan 27, 2014

First Posted Date

Jan 29, 2014Estimated

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

Jan 23, 2018

Last Update Posted Date

Jan 24, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Magdalena S. Prüß née Volz, Dr. med. Magdalena Volz, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

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

In the study we test whether transcranial direct current stimulation can reduce the perception of pain in patients with chronic inflammatory bowel diseases.

Hypothesis: Transcranial direct current stimulation can reduce the perception of pain in patients with chronic inflammatory bowel diseases.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active transcranial direct current stimulation	Active Comparator		Device: Transcranial direct current stimulation
Sham transcranial direct current stimulation	Sham Comparator		Device: Transcranial direct current stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcranial direct current stimulation	Device		Active transcranial direct current stimulation Sham transcranial direct current stimulation

Measure	Description	Time Frame
Pain pressure threshold		1 week

Measure	Description	Time Frame
Visual analoug scale - pain		1 week

Measure	Description	Time Frame
Quality of life		3 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inflammatory bowel disease
Chronic pain (more than 3 months)
Pain (VAS > 3/10)

Exclusion Criteria:

Contraindication to transcranial direct current stimulation
Pregnancy
Sever internal or psychiatric condition

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charite University Medicine		Berlin		12200	Germany

References Module

Citations

Not provided

Label	URL
Related Info	View source
Department of Gastroenterology, Infectiology and Rheumatology (including workspace nutrition medicine)	View source

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D003295	Convulsive Therapy
D013000	Psychiatric Somatic Therapies