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Completed

NCT Number: NCT05544604

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

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.

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Key information

Conditions

Post-Mastectomy Chronic Pain Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Egypt Cancer Institute

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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.

Primary outcomes

  1. chronic postmastectomy pain relief

    Time frame: VAS monitoring after 5th session

    pain relief on the VAS after the 5th session

  2. chronic postmastectomy pain relief

    Time frame: VAS monitoring after 15 days

    pain relief on the VAS after 15 days

  3. chronic postmastectomy pain relief

    Time frame: VAS monitoring one month later

    pain relief on the VAS 1 month later

Secondary outcomes

  1. VDS, LANSS and depression symptoms by HAM-D

    Time frame: VDS, LANSS and depression symptoms by HAM-D after 5th session

    VDS, LANSS and depression symptoms by HAM-D after the 5th session

  2. VDS, LANSS and depression symptoms by HAM-D

    Time frame: VDS, LANSS and depression symptoms by HAM-D after 15 days

    VDS, LANSS and depression symptoms by HAM-D after 15 days

  3. VDS, LANSS and depression symptoms by HAM-D

    Time frame: VDS, LANSS and depression symptoms by HAM-D after one month

    VDS, LANSS and depression symptoms by HAM-D 1 month later

Sponsors and collaborators

Lead sponsor

South Egypt Cancer Institute

Other

Collaborators

  • Assiut University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 16, 2022
Registry last updated
Dec 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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