Motor Cortex Versus Insula Stimulation Using Transcranial Current Stimulation on Chronic Post-mastectomy Pain

Effect of Motor Cortex Versus Insula Cortical Targets Stimulation Using Concentric Electrode Transcranial Direct Current Stimulation on Chronic Post-mastectomy Pain; a Randomized Sham Controlled Study

This study is designed to evaluate the effect of two concentric electrode transcranial direct current stimulation over the primary motor cortex versus insular cortical targets in post mastectomy neuropathic pain.

Study Overview

• Status: Completed
• Conditions: Post-Mastectomy Chronic Pain Syndrome
• Intervention / Treatment: Device: Transcranial direct current stimulation

Detailed Description

eighty patients within age group 18-65 years old with post mastectomy neuropathic pain that are resistant to medical treatment in the form of tramadol hydrochloride 100 mg twice daily, pregabalin 75 mg twice daily and Amitriptyline 25 mg once daily for at least two months or associated with significant adverse effect from medication will be involved in this study.

twenty patients will be randomly allocated into one of the study designed groups using serially numbered opaque closed envelopes. Each patient will be placed in the appropriate group after opening the corresponding sealed envelope. The patient will receive one of the following interventions either:

• active tDCS (2 mA) targeting the primary motor cortex of the contralateral side of the pain for 20 minute duration for five sessions in five consecutive days (one session /day),
• sham tDCS over the primary motor cortex in the same stimulation parameters will be used but the device will be turned off without patient knowledge after 30 seconds ,
• active tDCS (2mA) targeting the insula of the contralateral side of the pain for 20 minute duration for five sessions in five consecutive days (one session /day),
• sham tDCS over the insula in the same stimulation parameters will be used but the device will be turned off without patient knowledge after 30 seconds.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • South Egypt Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• eighty patients within age group 18-65 years old with post mastectomy neuropathic pain that are resistant to medical treatment in the form of tramadol hydrochloride 100 mg twice daily, pregabalin 75 mg twice daily and Amitriptyline 25 mg once daily for at least two months or associated with significant adverse effect from medication will be involved in this study.

Exclusion Criteria:

• We will exclude patients with intracranial metallic devices or with pacemakers or any other device. We also exclude those with extensive myocardial ischemia and those known to have epilepsy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group 1: active primary motor cortex stimulation; active tDCS (2 mA) targeting the primary motor cortex of the contralateral side of the pain for 20 minute duration for five sessions in five consecutive days (one session /day)	Device: Transcranial direct current stimulation; tDCS will be delivered with current strength of 2 mA for 20 min . Current will be applied through two concentric electrodes target electrode; return electrode. First we will fill the electrode cage with an electroconductive gel, and then position the electrodes, with the target electrode over the FDI hotspot, and finally we fasten the electrodes with a tubular net-shaped elastic bandage in mesh tissue, making sure that it will not push the electrode forward or backward. This procedure will aim at reducing contact impedance and at creating a uniform adherence between the whole surface of the electrodes and the scalp, avoiding uneven distribution of the current (Fertonani, 2015). We will position the central electrode (anode) according to the study group over C3 or C4 , the stimulating electrode will be placed on the scalp at T7 or T8 for the insular cortex per the 10-20 (EEG) system.
Sham Comparator: group 2 : sham primary motor cortex stimulation; sham tDCS over the primary motor cortex in the same stimulation parameters will be used but the device will be turned off without patient knowledge after 30 seconds.	Device: Transcranial direct current stimulation; tDCS will be delivered with current strength of 2 mA for 20 min . Current will be applied through two concentric electrodes target electrode; return electrode. First we will fill the electrode cage with an electroconductive gel, and then position the electrodes, with the target electrode over the FDI hotspot, and finally we fasten the electrodes with a tubular net-shaped elastic bandage in mesh tissue, making sure that it will not push the electrode forward or backward. This procedure will aim at reducing contact impedance and at creating a uniform adherence between the whole surface of the electrodes and the scalp, avoiding uneven distribution of the current (Fertonani, 2015). We will position the central electrode (anode) according to the study group over C3 or C4 , the stimulating electrode will be placed on the scalp at T7 or T8 for the insular cortex per the 10-20 (EEG) system.
Active Comparator: group 3 : active insula stimulation; active tDCS (2 mA) targeting the insula of the contralateral side of the pain for 20 minute duration for five sessions in five consecutive days (one session /day)	Device: Transcranial direct current stimulation; tDCS will be delivered with current strength of 2 mA for 20 min . Current will be applied through two concentric electrodes target electrode; return electrode. First we will fill the electrode cage with an electroconductive gel, and then position the electrodes, with the target electrode over the FDI hotspot, and finally we fasten the electrodes with a tubular net-shaped elastic bandage in mesh tissue, making sure that it will not push the electrode forward or backward. This procedure will aim at reducing contact impedance and at creating a uniform adherence between the whole surface of the electrodes and the scalp, avoiding uneven distribution of the current (Fertonani, 2015). We will position the central electrode (anode) according to the study group over C3 or C4 , the stimulating electrode will be placed on the scalp at T7 or T8 for the insular cortex per the 10-20 (EEG) system.
Sham Comparator: group 4 : sham insula stimulation; sham tDCS over the insula in the same stimulation parameters will be used but the device will be turned off without patient knowledge after 30 seconds.	Device: Transcranial direct current stimulation; tDCS will be delivered with current strength of 2 mA for 20 min . Current will be applied through two concentric electrodes target electrode; return electrode. First we will fill the electrode cage with an electroconductive gel, and then position the electrodes, with the target electrode over the FDI hotspot, and finally we fasten the electrodes with a tubular net-shaped elastic bandage in mesh tissue, making sure that it will not push the electrode forward or backward. This procedure will aim at reducing contact impedance and at creating a uniform adherence between the whole surface of the electrodes and the scalp, avoiding uneven distribution of the current (Fertonani, 2015). We will position the central electrode (anode) according to the study group over C3 or C4 , the stimulating electrode will be placed on the scalp at T7 or T8 for the insular cortex per the 10-20 (EEG) system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chronic postmastectomy pain relief	pain relief on the VAS after the 5th session	VAS monitoring after 5th session
chronic postmastectomy pain relief	pain relief on the VAS after 15 days	VAS monitoring after 15 days
chronic postmastectomy pain relief	pain relief on the VAS 1 month later	VAS monitoring one month later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VDS, LANSS and depression symptoms by HAM-D	VDS, LANSS and depression symptoms by HAM-D after the 5th session	VDS, LANSS and depression symptoms by HAM-D after 5th session
VDS, LANSS and depression symptoms by HAM-D	VDS, LANSS and depression symptoms by HAM-D after 15 days	VDS, LANSS and depression symptoms by HAM-D after 15 days
VDS, LANSS and depression symptoms by HAM-D	VDS, LANSS and depression symptoms by HAM-D 1 month later	VDS, LANSS and depression symptoms by HAM-D after one month

Collaborators and Investigators

• Sponsor: South Egypt Cancer Institute
• Collaborators: Assiut University
• Investigators: Principal Investigator: Khalid Mohamed Fares, Professor, South Egypt Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 14, 2022

Study Registration Dates

• First Submitted: March 29, 2020
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 16, 2022

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 453

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No