Effect of tDCS on Chronic Abdominal Visceral Pain in HCC Patients
Effect of the Transcranial Direct Current Stimulation (tDCS) of the Motor Cortex on Chronic Abdominal Pain in Patients With Hepatocellular Carcinoma
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
To evaluate the effect of transcranial direct current stimulation (tDCS) applied to the motor cortex to reduce chronic abdominal visceral pain in a group of participants with hepatocellular carcinoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedFirst Posted
Study publicly available on registry
October 10, 2016
CompletedOctober 10, 2016
October 1, 2016
1 year
March 26, 2016
October 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
visual analog scale (VAS)
measurement of reduction of chronic abdominal pain in cancer liver patients.
one month
verbal descriptor scale (VDS)
measurement of reduction of chronic abdominal pain in cancer liver patients.
one month
Secondary Outcomes (1)
Hamilton rating scale for depression (HAM-D)
one month
Study Arms (2)
Real tDCS
ACTIVE COMPARATORIn the active stimulation condition a constant current of active transcranial direct current stimulation (tDCS) of 2mA intensity was applied for 30 minutes,over primary motor cortex M1. The treatment was repeated every day for 10 consecutive days.
Sham tDCS
PLACEBO COMPARATORSham tDCS was applied using the same parameters but only for 30 seconds then the machine is deactivated.
Interventions
A battery driven DC stimulator (neuroConn Gmbh,98693 llmenau, Germany)
Eligibility Criteria
You may qualify if:
- All patients of above 18 years old, with malignant visceral pain due to primary liver cancer or on top of cirrhosis, resistant to medical treatment for at least 2 months or associated with significant adverse effect from medication will be involved in this study
You may not qualify if:
- Investigators will exclude patients with intracranial metallic devices or with pacemakers or any other device. Investigators also exclude those with extensive myocardial ischemia and those known to have epilepsy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Ibrahim NM, Abdelhameed KM, Kamal SMM, Khedr EMH, Kotb HIM. Effect of Transcranial Direct Current Stimulation of the Motor Cortex on Visceral Pain in Patients with Hepatocellular Carcinoma. Pain Med. 2018 Mar 1;19(3):550-560. doi: 10.1093/pm/pnx087.
PMID: 28605527DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident at Anaesthesia, ICU and pain management department,Assiut University
Study Record Dates
First Submitted
March 26, 2016
First Posted
October 10, 2016
Study Start
April 1, 2015
Primary Completion
April 1, 2016
Study Completion
August 1, 2016
Last Updated
October 10, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share