NCT02048137

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

2.9 years

First QC Date

January 11, 2014

Last Update Submit

January 23, 2018

Conditions

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • Pain pressure threshold

    1 week

Secondary Outcomes (1)

  • Visual analoug scale - pain

    1 week

Other Outcomes (1)

  • Quality of life

    3 weeks

Study Arms (2)

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

Transcranial direct current stimulationDEVICE
Active transcranial direct current stimulationSham transcranial direct current stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University Medicine

Berlin, 12200, Germany

Location

Related Links

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Magdalena Volz

Study Record Dates

First Submitted

January 11, 2014

First Posted

January 29, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Last Updated

January 24, 2018

Record last verified: 2018-01

Locations

DE(1)