Clinical trial NCT05544604: Motor Cortex Versus Insula Stimulation Using Transcranial Current Stimulation on Chronic Post-mastectomy Pain
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Mastectomy Chronic Pain Syndrome
Lead sponsor: South Egypt Cancer Institute
Sponsor class: OTHER
Collaborators: name: Assiut University
First posted: 2022-09-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: chronic postmastectomy pain relief
timeFrame: VAS monitoring after 5th session
measure: chronic postmastectomy pain relief
timeFrame: VAS monitoring after 15 days
measure: chronic postmastectomy pain relief
timeFrame: VAS monitoring one month later
Secondary outcomes:
measure: VDS, LANSS and depression symptoms by HAM-D
timeFrame: VDS, LANSS and depression symptoms by HAM-D after 5th session
measure: VDS, LANSS and depression symptoms by HAM-D
timeFrame: VDS, LANSS and depression symptoms by HAM-D after 15 days
measure: VDS, LANSS and depression symptoms by HAM-D
timeFrame: VDS, LANSS and depression symptoms by HAM-D after one month
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: South Egypt Cancer Institute
Study officials:
affiliation: South Egypt Cancer Institute
name: Khalid Mohamed Fares, Professor
role: PRINCIPAL_INVESTIGATOR
References: