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Clinical Trials/NCT02928237
NCT02928237CompletedNot Applicable

Effect of the Transcranial Direct Current Stimulation (tDCS) of the Motor Cortex on Chronic Abdominal Pain in Patients With Hepatocellular Carcinoma

Assiut University0 sites40 target enrollmentStarted: April 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Primary Endpoint
verbal descriptor scale (VDS)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

verbal descriptor scale (VDS)

Time Frame: one month

measurement of reduction of chronic abdominal pain in cancer liver patients.

visual analog scale (VAS)

Time Frame: one month

measurement of reduction of chronic abdominal pain in cancer liver patients.

Secondary Outcomes

  • Hamilton rating scale for depression (HAM-D)(one month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Khaled Mohamed Abdelhameed

Resident at Anaesthesia, ICU and pain management department,Assiut University

Assiut University

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