Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522685
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Neural and Immune Correlates of CIPN and Possible Analgesic Effect of Non-invasive Motor Cortex Stimulation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neural and Immune Correlates of Painful Chemotherapy-Induced Neuropathy Feasibility and Preliminary Efficacy of a Motor Cortex Non-Invasive Brain Stimulation Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NIBS4CIPN
Brief 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 White NHW patients
Currently only one medication duloxetine is approved for treating CIPN but it doesnt 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 brains 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
1 Test if tDCS is a helpful treatment for painful CIPN
2 Investigate how CIPN affects brain function in NHB and NHW patients
3 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 brains pain response system This project aims to address health disparities and improve outcomes for urban communities particularly in Baltimore
Currently only one medication duloxetine is approved for treating CIPN but it doesnt 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 brains 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
1 Test if tDCS is a helpful treatment for painful CIPN
2 Investigate how CIPN affects brain function in NHB and NHW patients
3 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 brains 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 ratio16-24 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 RCMIMorgan to understand and combat urban health disparity issues in the City of Baltimore and elsewhere
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None