Effect of tDCS on Chronic Abdominal Visceral Pain in HCC Patients

NCT ID: NCT02928237

Last Updated: 2016-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-08-31

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.

Conditions

Abdominal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Real tDCS

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.

Group Type: ACTIVE_COMPARATOR

transcranial direct current stimulation tDCS

Intervention Type: DEVICE

A battery driven DC stimulator (neuroConn Gmbh,98693 llmenau, Germany)

Sham tDCS

Sham tDCS was applied using the same parameters but only for 30 seconds then the machine is deactivated.

Group Type: PLACEBO_COMPARATOR

transcranial direct current stimulation tDCS

Intervention Type: DEVICE

A battery driven DC stimulator (neuroConn Gmbh,98693 llmenau, Germany)

Interventions

transcranial direct current stimulation tDCS

A battery driven DC stimulator (neuroConn Gmbh,98693 llmenau, Germany)

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Khaled Mohamed Abdelhameed

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 28605527 (View on PubMed)

Other Identifiers

481186

Identifier Type: -

Identifier Source: org_study_id