Effect of tDCS on Chronic Abdominal Visceral Pain in HCC Patients
Primary Purpose
Abdominal Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transcranial direct current stimulation tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Pain focused on measuring tDCS, cancer liver, chronic abdominal pain, VAS, VDS, HAM-D, BPI, analgesia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Real tDCS
Sham tDCS
Arm Description
In 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 was applied using the same parameters but only for 30 seconds then the machine is deactivated.
Outcomes
Primary Outcome Measures
visual analog scale (VAS)
measurement of reduction of chronic abdominal pain in cancer liver patients.
verbal descriptor scale (VDS)
measurement of reduction of chronic abdominal pain in cancer liver patients.
Secondary Outcome Measures
Hamilton rating scale for depression (HAM-D)
Measurement of reduction of depression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02928237
Brief Title
Effect of tDCS on Chronic Abdominal Visceral Pain in HCC Patients
Official Title
Effect of the Transcranial Direct Current Stimulation (tDCS) of the Motor Cortex on Chronic Abdominal Pain in Patients With Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
Detailed Description
This study will be carried out in Assiut University Hospital pain clinic and in participation of department of neuropsychiatry in Assiut University Hospital. After obtaining approval of hospital ethical committee, informed written consent will be taken from all patients with malignant visceral pain to be involved in this study.
In these study investigators test the hypothesis that Does transcranial direct current stimulation induce analgesia in chronic abdominal visceral pain due to liver cancer ?
Preparation:
The patient will seat in a comfortable chair and will be asked to relax as much as possible. tDCS was delivered using a battery driven DC stimulator (neuroConn Gmbh,98693 llmenau, Germany). Current was delivered by electrodes encased in sponge pads soaked with 1% saline solution. The machine was kept behind the participant and out of their view at all times. For both the active and sham conditions, the anode was placed over the motor cortex of the patient and the cathode was placed over the contralateral supraorbital region. Electrodes were secured using soft elastic straps.
In the active stimulation condition a constant current of 2mA intensity was applied for 30 minutes with a 5-second ramp phase at the beginning. In the sham stimulation condition the machine was activated for 30 seconds using identical parameters but was then switched off without the patient's knowledge. This sham control is commonly employed because over the initial 30 seconds of stimulation, an initial sensation of tingling under the electrode fades away. Patients are less likely to distinguish active from sham conditions if the initial period of tingling is present in both.
Patients were evaluated by verbal descriptor scale (VDS), visual analog scale (VAS), and Hamilton rating scale for depression (HAM-D) at the baseline, after 1st, 5th, 10th session, and 1 month after end of sessions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain
Keywords
tDCS, cancer liver, chronic abdominal pain, VAS, VDS, HAM-D, BPI, analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Real tDCS
Arm Type
Active Comparator
Arm Description
In 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.
Arm Title
Sham tDCS
Arm Type
Placebo Comparator
Arm Description
Sham tDCS was applied using the same parameters but only for 30 seconds then the machine is deactivated.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation tDCS
Intervention Description
A battery driven DC stimulator (neuroConn Gmbh,98693 llmenau, Germany)
Primary Outcome Measure Information:
Title
visual analog scale (VAS)
Description
measurement of reduction of chronic abdominal pain in cancer liver patients.
Time Frame
one month
Title
verbal descriptor scale (VDS)
Description
measurement of reduction of chronic abdominal pain in cancer liver patients.
Time Frame
one month
Secondary Outcome Measure Information:
Title
Hamilton rating scale for depression (HAM-D)
Description
Measurement of reduction of depression
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
28605527
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of tDCS on Chronic Abdominal Visceral Pain in HCC Patients
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