An interventional study of transcranial direct current stimulation Soterix REMOTE 1x1 miniCT in Chemotherapy-induced Peripheral Neuropathy, sponsored by Morgan State University. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Morgan State University · Not applicable, Interventional, and Device feasibility
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:
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.
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.
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →Morgan State University is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: transcranial direct current stimulation Soterix REMOTE 1x1 miniCT
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.
Device: transcranial direct current stimulation 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.
Also known as: tDCS, Soterix REMOTE 1x1 miniCT
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
Time frame: 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)
Time frame: 2 weeks
Cortical thickness
Cortical thickness comparison between non-Hispanic blacks and non-Hispanic whites
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 10 minutes
Brief pain inventory short form score
Comparing active to sham transcranial direct current stimulation in non-Hispanic black participants and non-Hispanic white participants
Time frame: 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
Time frame: At 6 week follow-up
Plan to share: 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.
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peripheral Nervous System Diseases→
Morgan State University