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

NCT05544604 | Completed

• 1 other identifier: 453
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-Mastectomy Chronic Pain Syndrome

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• VDS, LANSS and depression symptoms by HAM-D

  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

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

Study Arms (4)

group 1: active primary motor cortex stimulation

ACTIVE COMPARATOR

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

group 2 : sham primary motor cortex stimulation

SHAM COMPARATOR

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

group 3 : active insula stimulation

ACTIVE COMPARATOR

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

group 4 : sham insula stimulation

SHAM COMPARATOR

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

Interventions

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.

group 1: active primary motor cortex stimulation; group 2 : sham primary motor cortex stimulation; group 3 : active insula stimulation; group 4 : sham insula stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• South Egypt Cancer Institute: lead
• Assiut University: collaborator

Study Sites (1)

South Egypt Cancer Institute

Asyut, Egypt

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Khalid Mohamed Fares, Professor

  South Egypt Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: serially numbered opaque closed envelopes. Each patient will be placed in the appropriate group after opening the corresponding sealed envelope
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 Record Dates

• First Submitted: March 29, 2020
• First Posted: September 16, 2022
• Study Start: May 1, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 14, 2022
• Last Updated: December 19, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)