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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- chronic postmastectomy pain relief
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
serially numbered opaque closed envelopes. Each patient will be placed in the appropriate group after opening the corresponding sealed envelope
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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)
Intervention: Transcranial direct current stimulation (Device)
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.
Intervention: Transcranial direct current stimulation (Device)
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)
Intervention: Transcranial direct current stimulation (Device)
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.
Intervention: Transcranial direct current stimulation (Device)
Outcomes
Primary Outcomes
chronic postmastectomy pain relief
Time Frame: VAS monitoring one month later
pain relief on the VAS 1 month later
chronic postmastectomy pain relief
Time Frame: VAS monitoring after 5th session
pain relief on the VAS after the 5th session
chronic postmastectomy pain relief
Time Frame: VAS monitoring after 15 days
pain relief on the VAS after 15 days
Secondary Outcomes
- VDS, LANSS and depression symptoms by HAM-D(VDS, LANSS and depression symptoms by HAM-D after one month)
- 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)
Investigators
Mohannad Ahmed Mohamed
Principal Investigator
South Egypt Cancer Institute