Post-Mastectomy Chronic Pain SyndromeNCT05544604
Motor Cortex Versus Insula Stimulation Using Transcranial Current Stimulation on Chronic Post-mastectomy Pain
A study testing Transcranial direct current stimulation in people with Post-Mastectomy Chronic Pain Syndrome, run by South Egypt Cancer Institute at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Mastectomy Chronic Pain Syndrome
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 14 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Post-Mastectomy Chronic Pain Syndrome
- Being tested
- Transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: 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) Receives: 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. Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
chronic postmastectomy pain relief
pain relief on the VAS after the 5th session
Measured: VAS monitoring after 5th session
chronic postmastectomy pain relief
pain relief on the VAS after 15 days
Measured: VAS monitoring after 15 days
chronic postmastectomy pain relief
pain relief on the VAS 1 month later
Measured: 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 the 5th session
Measured: 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
Measured: 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
Measured: VDS, LANSS and depression symptoms by HAM-D after one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 May 2020
- Primary completion30 Dec 2021
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Mastectomy Chronic Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Principal investigator, Mohannad Ahmed Mohamed, South Egypt Cancer Institute
- Investigators
- Khalid Mohamed Fares, Professor, Principal investigator, South Egypt Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544604
- Sponsor's protocol ID
- 453
- Status last verified
- Dec 2022
- First submitted
- 29 Mar 2020
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05544604
- Acronym / sponsor ID
- 453
- Conditions
- Post-Mastectomy Chronic Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| group 1: active primary motor cortex stimulation | Active comparator | Device: Transcranial direct current stimulationactive 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) |
| group 2 : sham primary motor cortex stimulation | Sham comparator | Device: Transcranial direct current stimulationsham 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. |
| group 3 : active insula stimulation | Active comparator | Device: Transcranial direct current stimulationactive 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) |
| group 4 : sham insula stimulation | Sham comparator | Device: Transcranial direct current stimulationsham 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 may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulationtDCS 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. | Device | group 1: active primary motor cortex stimulation, group 2 : sham primary motor cortex stimulation, group 3 : active insula stimulation, group 4 : sham insula stimulation |
Primary outcome
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
chronic postmastectomy pain relief
Time frame: VAS monitoring one month later
pain relief on the VAS 1 month later
3 secondary outcomes
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
Time frame: VDS, LANSS and depression symptoms by HAM-D after 15 days
VDS, LANSS and depression symptoms by HAM-D
Time frame: VDS, LANSS and depression symptoms by HAM-D after one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khalid Mohamed Fares, Professor principal investigator
South Egypt Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Post-Mastectomy Chronic Pain Syndrome, run by South Egypt Cancer Institute at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chronic postmastectomy pain relief (time frame: VAS monitoring after 5th session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022.