Chemotherapy-induced Peripheral NeuropathyNIBS4CIPNNCT06522685
Neural and Immune Correlates of CIPN and Possible Analgesic Effect of Non-invasive Motor Cortex Stimulation
A study testing transcranial direct current stimulation Soterix REMOTE 1x1 miniCT in people with Chemotherapy-induced Peripheral Neuropathy, run by Morgan State University at 2 sites in United States.
Trial summary
Over half of cancer patients receiving common chemotherapy treatments experience painful nerve damage called chemotherapy-induced peripheral neuropathy (CIPN). Non-Hispanic Black (NHB) patients are more likely to suffer from this condition and more often need to reduce their chemotherapy doses compared to Non-Hispanic… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- transcranial direct current stimulation Soterix REMOTE 1x1 miniCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2025to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to read, write, and comprehend English
- Non-Hispanic White or Non-Hispanic Black
- Stable medication dosage over previous 4 weeks
- Completed primary surgery or chemotherapy for cancer at least 3 months prior to signing consent form
- Diagnosed with painful chemotherapy-induced neuropathy
Who cannot join
- Chronic pain due to another painful condition (e.g., fibromyalgia, chronic low back pain, etc.)
- Any neurological deficits (e.g., lower extremity weakness or bowel/bladder dysfunction, etc.)
- Deficient folate levels (<7 nmol/ml serum)
- Deficient vitamin B12 levels (<200 pg/mL serum)
- Deficient Vitamin D levels (<50 nmol/L or <20 ng/ml)
- Comorbidities affecting sensorimotor function (e.g., multiple sclerosis, diabetes, etc.)
Show all 20Show fewer
- Unstable mental health condition (acute medical management/hospitalization in the past 6 mo.)
- Elevated hemoglobin A1c levels indicative of uncontrolled diabetes (>6.5%)
- Self-reported Substance abuse (current)
- Drug test positive for illicit drugs except THC
- Excessive alcohol consumption defined as: 1) More than 3 glasses of wine a day; 2) More than 3 beers a day; 3) More than 60 mL of hard liquor a day
- Presence of cardiac pacemaker or automatic implantable cardioverter-defibrillator (AICD).
- Pregnancy, lactation (will be screened with urine pregnancy test)
- Non-removable metal or tattoos around head, excepting dental appliances and fillings
- Use of implantable copper birth control device
- History of frequent severe headaches
- Unstable coronary artery disease
- Uncontrolled Seizure disorder
- Uncontrolled hypertension
- Stage IV cancer
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Cynthia Renn
Baltimore, Maryland, 21201
Cynthia Renn, PhD, 410-706-5736, renn@umaryland.edu
Morgan State University
Baltimore, Maryland, 21251
Timothy J Meeker, PhD, 443-885-4468, timothy.meeker@morgan.edu
About this study
Official title: Neural and Immune Correlates of Painful Chemotherapy-Induced Neuropathy, Feasibility and Preliminary Efficacy of a Motor Cortex Non-Invasive Brain Stimulation Intervention
Over half of cancer patients receiving common chemotherapy treatments experience painful nerve damage called chemotherapy-induced peripheral neuropathy (CIPN). Non-Hispanic Black (NHB) patients are more likely to suffer from this condition and more often need to reduce their chemotherapy doses compared to Non-Hispanic White (NHW) patients.
Currently, only one medication, duloxetine, is approved for treating CIPN, but it doesn't work for everyone. A new approach, transcranial direct current stimulation (tDCS), shows promise as a safe and effective treatment. tDCS can be done at home and reduces the need for hospital visits.
Read more
Research indicates that tDCS can improve pain responses in the brain's pain control network. There are differences in pain sensitivity and brain activity related to pain between NHB and NHW individuals, which may influence the effectiveness of treatments.
This research aims to conduct a study to:
- Test if tDCS is a helpful treatment for painful CIPN.
- Investigate how CIPN affects brain function in NHB and NHW patients.
- Examine the role of inflammation in CIPN and its connection to pain severity and brain function.
The investigators expect that NHB patients will benefit more from tDCS due to differences in their brain's pain response system. This project aims to address health disparities and improve outcomes for urban communities, particularly in Baltimore.
Read the detailed description
More than half of patients treated with commonly used platinum- and taxane-based anti-cancer agents suffer painful chemotherapy-induced peripheral neuropathy (CIPN). Non-Hispanic Black (NHB) patients have a greater risk (risk ratio=1.6-2.4) of experiencing clinically relevant CIPN and consequent chemotherapy dose reductions compared to non-Hispanic Whites (NHWs). Despite the greater risk of painful CIPN in NHB cancer patients, clinical trials in patients suffering with CIPN have historically included homogeneous patient populations of NHWs. Only duloxetine is approved to treat painful CIPN and is not effective for or tolerated by all patients. Transcranial direct current stimulation (tDCS) of the motor cortex is emerging as a promising, safe, and effective intervention for the pain of neuropathy. An additional benefit of tDCS is that it can be administered at home and supervised remotely, minimizing stressful visits to a hospital venue for treatment. A recent randomized experimental study in healthy individuals completed by the PI showed that one 20-minute session of motor cortex tDCS reduced capsaicin-induced hyperalgesia. To understand the mechanism of pain ameliorating effects of motor cortex tDCS, the PI found enhanced neurophysiological responses of the descending pain modulatory network (DPMN), a group of brain structures activated in response to painful stimuli, after active compared to sham stimulation. Previous investigations have observed differences in opioid receptor binding and pain responses in the DPMN (notably the cingulate cortex and ventral striatum) between healthy NHBs and NHWs as well as differences in pain sensitivity. Likely relevant to the mechanism of CIPN, PET scanning of chemotherapy patients reveals neuroinflammation throughout the brain. The facts that 1) NHB individuals experience a greater rate of CIPN, but have not been represented in relevant clinical studies, 2) non-invasive tDCS is emerging as a safe and effective treatment for neuropathic pain and can be implemented in the home 3) the DPMN is implicated in central pain responses and is activity is enhanced after tDCS and 4) neuroinflammation likely plays a role in CIPN have led us to the present research plan. The overarching goal of this proposal to conduct an exploratory double-blind randomized controlled trial (RCT) addressing 3 specific aims: 1) determine the feasibility and efficacy of active tDCS targeting motor cortex as an analgesic and antihyperalgesic intervention in patients with painful CIPN, 2) determine structural and functional brain correlates of painful CIPN in the DPMN in NHBs and NHWs, and 3) determine inflammatory mediators in patients with painful CIPN and their relationship to the severity of painful CIPN and DPMN structure and function. The investigators expect NHB subjects will experience greater therapeutic effects of tDCS compared to NHW subjects, since NHBs have a dysregulated DPMN potentially affected by neuroinflammation. The goals of this project align with the mission of RCMI@Morgan to understand and combat urban health disparity issues in the City of Baltimore and elsewhere.
- Being tested
- transcranial direct current stimulation Soterix REMOTE 1x1 miniCT
- Keywords
- Chronic Pain, Neuropathy, Neuropathic Pain, Non-invasive brain stimulation, transcranial direct current stimulation
- Medical subject headings
- Chronic Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation Soterix REMOTE 1x1 miniCTDevice
Also called tDCS, Soterix REMOTE 1x1 miniCT
Soterix Medical REMOTE Neuromodulation is the only system with device, accessories, and software designed for deployed use. Safe transcranial Electrical Stimulation requires advanced systems designed for consistency and control. REMOTE Neuromodulation is the only system designed from the ground up to allow translation of clinical tES, including tDCS protocols, to diverse deployed environments, while maintaining medical standards.
| Study group | Role | What they receive |
|---|---|---|
| Left motor cortex targeted anodal transcranial direct current stimulation | Experimental | Active left motor cortex targeted anodal transcranial direct current stimulation at 2 milliamperes applied for 20 minutes once daily on Monday through Friday for two consecutive weeks. Receives: Device: transcranial direct current stimulation Soterix REMOTE 1x1 miniCT |
| Left motor cortex targeted sham transcranial direct current stimulation | Sham comparator | Active left motor cortex targeted anodal transcranial direct current stimulation at 0 milliamperes applied for 20 minutes once daily on Monday through Friday for two consecutive weeks. The sham consists of a ramp up to 2 mA and immediate ramp down to 0 mA at the beginning of the 20 minute period and a ramp up to 2 mA and immediate ramp down to 0 mA at the end of the 20 minute period. Receives: Device: transcranial direct current stimulation Soterix REMOTE 1x1 miniCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants able to adhere to the at home remote stimulation protocol
Number of participants able to adhere to the at home study protocol comparing non-Hispanic blacks to non-Hispanic whites for both active and sham stimulation groups
Measured: 2 weeks
Number of side effects reported on the transcranial direct current stimulation side effect questionnaire
Number of side effects reported on the transcranial direct current stimulation side effect questionnaire comparing non-Hispanic blacks to non-Hispanic whites for both active and sham stimulation groups (n=20 per group; 4 groups)
Measured: 2 weeks
Cortical thickness
Cortical thickness comparison between non-Hispanic blacks and non-Hispanic whites
Measured: 10 minutes
Blood oxygen level dependent (BOLD) response to sharp mechanical stimuli
Comparison between non-Hispanic black and non-Hispanic white participants with and without painful chemotherapy induced peripheral neuropathy
Measured: 10 minutes
Blood oxygen level dependent (BOLD) response to painful heat stimuli
Comparison between non-Hispanic black and non-Hispanic white participants with and without painful chemotherapy induced peripheral neuropathy
Measured: 10 minutes
Blood oxygen level dependent (BOLD) response to cold heat stimuli
Comparison between non-Hispanic black and non-Hispanic white participants with and without painful chemotherapy induced peripheral neuropathy
Measured: 10 minutes
Secondary outcomes (2)
Brief pain inventory short form score
Comparing active to sham transcranial direct current stimulation in non-Hispanic black participants and non-Hispanic white participants
Measured: 2 weeks
Brief pain inventory short form score
Comparing active to sham transcranial direct current stimulation in non-Hispanic black participants and non-Hispanic white participants
Measured: At 6 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Mar 2025 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-Blind Sham-controlled Parallel comparing feasibility in non-Hispanic black participants to non-Hispanic white participants (2 arms, 2 groups each arm; total 4 groups with 20 participants in a group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morgan State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, Baltimore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522685
- Sponsor's protocol ID
- HP-00111489
- Acronym
- NIBS4CIPN
- Status last verified
- Feb 2025
- First submitted
- 17 Jul 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual Participant Data will be shared through supplementary materials in primary journals and by 01/2030 are planned to be shared in data repositories or journals.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural and Immune Correlates of Painful Chemotherapy-Induced Neuropathy, Feasibility and Preliminary Efficacy of a Motor Cortex Non-Invasive Brain Stimulation Intervention
- ClinicalTrials.gov ID
- NCT06522685
- Acronym / sponsor ID
- NIBS4CIPN / HP-00111489
- Keywords
- Chronic Pain, Neuropathy, Neuropathic Pain, Non-invasive brain stimulation, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Morgan State UniversityUniversity, hospital or other
- Collaborators
- University of Maryland, Baltimore
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 26 Jul 2024 (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.
Over half of cancer patients receiving common chemotherapy treatments experience painful nerve damage called chemotherapy-induced peripheral neuropathy (CIPN). Non-Hispanic Black (NHB) patients are more likely to suffer from this condition and more often need to reduce their chemotherapy doses compared to Non-Hispanic White (NHW) patients.
Currently, only one medication, duloxetine, is approved for treating CIPN, but it doesn't work for everyone. A new approach, transcranial direct current stimulation (tDCS), shows promise as a safe and effective treatment. tDCS can be done at home and reduces the need for hospital visits.
Research indicates that tDCS can improve pain responses in the brain's pain control network. There are differences in pain sensitivity and brain activity related to pain between NHB and NHW individuals, which may influence the effectiveness of treatments.
This research aims to conduct a study to:
- Test if tDCS is a helpful treatment for painful CIPN.
- Investigate how CIPN affects brain function in NHB and NHW patients.
- Examine the role of inflammation in CIPN and its connection to pain severity and brain function.
The investigators expect that NHB patients will benefit more from tDCS due to differences in their brain's pain response system. This project aims to address health disparities and improve outcomes for urban communities, particularly in Baltimore.
Detailed description
More than half of patients treated with commonly used platinum- and taxane-based anti-cancer agents suffer painful chemotherapy-induced peripheral neuropathy (CIPN). Non-Hispanic Black (NHB) patients have a greater risk (risk ratio=1.6-2.4) of experiencing clinically relevant CIPN and consequent chemotherapy dose reductions compared to non-Hispanic Whites (NHWs). Despite the greater risk of painful CIPN in NHB cancer patients, clinical trials in patients suffering with CIPN have historically included homogeneous patient populations of NHWs. Only duloxetine is approved to treat painful CIPN and is not effective for or tolerated by all patients. Transcranial direct current stimulation (tDCS) of the motor cortex is emerging as a promising, safe, and effective intervention for the pain of neuropathy. An additional benefit of tDCS is that it can be administered at home and supervised remotely, minimizing stressful visits to a hospital venue for treatment. A recent randomized experimental study in healthy individuals completed by the PI showed that one 20-minute session of motor cortex tDCS reduced capsaicin-induced hyperalgesia. To understand the mechanism of pain ameliorating effects of motor cortex tDCS, the PI found enhanced neurophysiological responses of the descending pain modulatory network (DPMN), a group of brain structures activated in response to painful stimuli, after active compared to sham stimulation. Previous investigations have observed differences in opioid receptor binding and pain responses in the DPMN (notably the cingulate cortex and ventral striatum) between healthy NHBs and NHWs as well as differences in pain sensitivity. Likely relevant to the mechanism of CIPN, PET scanning of chemotherapy patients reveals neuroinflammation throughout the brain. The facts that 1) NHB individuals experience a greater rate of CIPN, but have not been represented in relevant clinical studies, 2) non-invasive tDCS is emerging as a safe and effective treatment for neuropathic pain and can be implemented in the home 3) the DPMN is implicated in central pain responses and is activity is enhanced after tDCS and 4) neuroinflammation likely plays a role in CIPN have led us to the present research plan. The overarching goal of this proposal to conduct an exploratory double-blind randomized controlled trial (RCT) addressing 3 specific aims: 1) determine the feasibility and efficacy of active tDCS targeting motor cortex as an analgesic and antihyperalgesic intervention in patients with painful CIPN, 2) determine structural and functional brain correlates of painful CIPN in the DPMN in NHBs and NHWs, and 3) determine inflammatory mediators in patients with painful CIPN and their relationship to the severity of painful CIPN and DPMN structure and function. The investigators expect NHB subjects will experience greater therapeutic effects of tDCS compared to NHW subjects, since NHBs have a dysregulated DPMN potentially affected by neuroinflammation. The goals of this project align with the mission of RCMI@Morgan to understand and combat urban health disparity issues in the City of Baltimore and elsewhere.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-Blind Sham-controlled Parallel comparing feasibility in non-Hispanic black participants to non-Hispanic white participants (2 arms, 2 groups each arm; total 4 groups with 20 participants in a group.
| Arm | Type | Receives |
|---|---|---|
| Left motor cortex targeted anodal transcranial direct current stimulation | Experimental | Device: transcranial direct current stimulation Soterix REMOTE 1x1 miniCTActive left motor cortex targeted anodal transcranial direct current stimulation at 2 milliamperes applied for 20 minutes once daily on Monday through Friday for two consecutive weeks. |
| Left motor cortex targeted sham transcranial direct current stimulation | Sham comparator | Device: transcranial direct current stimulation Soterix REMOTE 1x1 miniCTActive left motor cortex targeted anodal transcranial direct current stimulation at 0 milliamperes applied for 20 minutes once daily on Monday through Friday for two consecutive weeks. The sham consists of a ramp up to 2 mA and immediate ramp down to 0 mA at the beginning of the 20 minute period and a ramp up to 2 mA and immediate ramp down to 0 mA at the end of the 20 minute period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to read, write, and comprehend English
- Non-Hispanic White or Non-Hispanic Black
- Stable medication dosage over previous 4 weeks
- Completed primary surgery or chemotherapy for cancer at least 3 months prior to signing consent form
- Diagnosed with painful chemotherapy-induced neuropathy
Key exclusion criteria (20 listed)
- Chronic pain due to another painful condition (e.g., fibromyalgia, chronic low back pain, etc.)
- Any neurological deficits (e.g., lower extremity weakness or bowel/bladder dysfunction, etc.)
- Deficient folate levels (<7 nmol/ml serum)
- Deficient vitamin B12 levels (<200 pg/mL serum)
- Deficient Vitamin D levels (<50 nmol/L or <20 ng/ml)
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 stimulation Soterix REMOTE 1x1 miniCTAlso: tDCS, Soterix REMOTE 1x1 miniCTSoterix Medical REMOTE Neuromodulation is the only system with device, accessories, and software designed for deployed use. Safe transcranial Electrical Stimulation requires advanced systems designed for consistency and control. REMOTE Neuromodulation is the only system designed from the ground up to allow translation of clinical tES, including tDCS protocols, to diverse deployed environments, while maintaining medical standards. | Device | Left motor cortex targeted anodal transcranial direct current stimulation, Left motor cortex targeted sham transcranial direct current stimulation |
Primary outcome
Number of participants able to adhere to the at home remote stimulation protocol
Time frame: 2 weeks
Number of participants able to adhere to the at home study protocol comparing non-Hispanic blacks to non-Hispanic whites for both active and sham stimulation groups
Number of side effects reported on the transcranial direct current stimulation side effect questionnaire
Time frame: 2 weeks
Number of side effects reported on the transcranial direct current stimulation side effect questionnaire comparing non-Hispanic blacks to non-Hispanic whites for both active and sham stimulation groups (n=20 per group; 4 groups)
Cortical thickness
Time frame: 10 minutes
Cortical thickness comparison between non-Hispanic blacks and non-Hispanic whites
Blood oxygen level dependent (BOLD) response to sharp mechanical stimuli
Time frame: 10 minutes
Comparison between non-Hispanic black and non-Hispanic white participants with and without painful chemotherapy induced peripheral neuropathy
Blood oxygen level dependent (BOLD) response to painful heat stimuli
Time frame: 10 minutes
Comparison between non-Hispanic black and non-Hispanic white participants with and without painful chemotherapy induced peripheral neuropathy
Blood oxygen level dependent (BOLD) response to cold heat stimuli
Time frame: 10 minutes
Comparison between non-Hispanic black and non-Hispanic white participants with and without painful chemotherapy induced peripheral neuropathy
2 secondary outcomes
Brief pain inventory short form score
Time frame: 2 weeks
Brief pain inventory short form score
Time frame: At 6 week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: Yes. Individual Participant Data will be shared through supplementary materials in primary journals and by 01/2030 are planned to be shared in data repositories or journals.
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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.
2 sites 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 Soterix REMOTE 1x1 miniCT in people with Chemotherapy-induced Peripheral Neuropathy, run by Morgan State University at 2 sites in United States.
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 5 inclusion and 20 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: opening soon, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timothy J Meeker, PhD (443-885-4468, timothy.meeker@morgan.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants able to adhere to the at home remote stimulation protocol (time frame: 2 weeks). The study lists 6 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 6 Feb 2025.