Neurosciences Clinical Trials
Evaluating the Functionality of a Low Intensity Cranial PEMF Device in Improving chemotherapy-Induced Peripheral Neuropathy Symptoms
What is the purpose of this study?
This study is intended to identify the functionality of the SHIFT device in reducing neuropathic pain and comorbid symptoms associated with CIPN.
Eligibility
Patient is 18 years or older
Patient is able to use a smart phone and willing to receive text messages
Patient is able and willing to follow instructions, including study procedures
Patient is able to provide informed consent
Patient has a CIPN disorder (CTCAEv5 Grade 2 (moderate pain/neuropathy symptoms) or higher) as determined clinically by the physician or is patient reported based on National Cancer Institute Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE) subquestions on neuropathy and pain
Patient has completed their last dose of chemotherapy at least 3 months prior to enrollment
Patient has not participated in any other clinical study within the past 2 months that may influence the results of this study.
• Patient has a history of seizures
• Patient is hydrocephalic
• Patient has had a change in medical therapy related to treatment of neuropathy or chronic pain in the last 14 days
• Patient has received repetitive transcranial magnetic stimulation (rTMS) in the last 60 days
• Patient has an implanted device or metal in the brain
• Patient has history of brain bleed in the last 6 months
• Patient has history of suicidal behavior, bipolar disorder, schizophrenia
• Patient has active radiation over the scalp
• Primary brain tumor or brain metastases
• Patient currently participates in other neuropathic pain studies
• Patient has any other medical condition that would prevent them from participating, including, but not limited to scalp wounds, hyperhidrosis, sensitive scalp, rash
• Patient who is pregnant
• Patient who requires legally authorized representative.
Where can I participate?
Hoag Hospital Newport Beach
1 Hoag
Newport Beach, CA 92663
What is the full name of this Clinical Trial?
Evaluating the Functionality of a Low Intensity Cranial PEMF Device in Improving chemotherapy-Induced Peripheral Neuropathy Symptoms
- Principal InvestigatorAaron Przybysz, MD
- Co-InvestigatorsCarlos Becerra, M.D., Tara Seery, M.D., Steven Grossman, M.D., Ph.D., Benjamin Goldenson, M.D., Ph.D., Pooja Motwani, M.D., Chaitali Nangia, M.D., Yaser Homsi, M.D., Sharmeen Mahmoud, M.D., Monica Mita, M.D., Alberto Mendivil, M.D., Tiffany Beck, M.D., Monica Levine, M.D., Lisa Abeid, M.D., John Brown, M.D., Antonio Castaneda, M.D.
- Age GroupAdult, Older Adult
- How do I learn more about this study?Laurie Hendricks, MSN, RN, OCN
laurie.hendricks@hoag.org
https://www.hoag.org/institute/neurosciences/
Hoag’s Pickup Family Neurosciences Institute offers Orange County’s most comprehensive neurologic care, with multidisciplinary specialists, advanced technology, and evidence-based treatment for complex brain, spine, and nervous system conditions. Patients have access to leading programs in brain tumors, memory and cognitive disorders, multiple sclerosis, epilepsy, Parkinson’s and movement disorders, headache and migraine, stroke, and clinical trials.
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