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Transcranial direct current stimulation

Phase 2

Inflammatory Bowel Disease | Unknown | Gastrointestinal |Pulmonx Corporation|Last Updated: Jan 24, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Transcranial direct current stimulation · 1 trial · 1 indication

Phase 2 1
NCT02433470Association of Functional Changes in the Brain and the Perception of Pain in Patients With Chronic Inflammatory Bowel Diseases (IBD)Inflammatory Bowel Disease
COMPLETED20 Analytics
PHASE2COMPLETED
Association of Functional Changes in the Brain and the Perception of Pain in Patients With Chronic Inflammatory Bowel Diseases (IBD)
Inflammatory Bowel Disease
NCT0243347020
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Study Endpoints

Primary Endpoints

Functional and/or structural changes in the brain measured with cerebral MRI
1 week

Participants will be followed for 2 weeks

Changes in perception of pain measured with visual analogue scale and pain pressure threshold
2 weeks

Participants will be followed for 2 weeks

Secondary Endpoints

Changes in quality of life
2 weeks
Changes in functional symptoms (questionnaire: Irritable bowel syndrome - severity scoring system (IBS-SSS))
2 weeks
Changes in activity indices (Harvey-Bradshaw Index (HBI) or simple clinical colitis activity index)
2 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Active tDCSACTIVE_COMPARATORActive transcranial direct current stimulation
Sham tDCSSHAM_COMPARATORSham transcranial direct current stimulation

Interventions

NameTypeDescription
Transcranial direct current stimulationDEVICETranscranial direct current stimulation over the motor cortex
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Inflammatory bowel disease * Chronic pain (more than 3 months) * Pain (VAS \> 3/10) Exclusion Criteria: * Contraindication to transcranial direct current stimulation * Contraindications to magnetic resonance imaging (MRI) * Pregnancy * Sever internal or psychiatric condition

Countries:Germany
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