Viewing Study NCT06324344



Ignite Creation Date: 2024-05-06 @ 8:17 PM
Last Modification Date: 2024-10-26 @ 3:24 PM
Study NCT ID: NCT06324344
Status: RECRUITING
Last Update Posted: 2024-03-25
First Post: 2024-03-15

Brief Title: Transcutaneous Electrical Nerve Stimulation TENS for Chemotherapy Induced Peripheral Neuropathy CIPN
Sponsor: Baylor College of Medicine
Organization: Baylor College of Medicine

Study Overview

Official Title: Transcutaneous Electrical Nerve Stimulation for Lower Extremity in Patients With Neurogenic Pain - A Proof Concept Randomized Clinical Trial
Status: RECRUITING
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this pilot study is to examine the acceptability and proof of concept effectiveness of a wireless Transcutaneous Electrical Nerve Stimulation TENS technology to address Chemotherapy Induced Peripheral Neuropathy CIPN Participants who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned with ratio of 11 into two groups The patients and clinicians will be blinded for group allocation One group will utilize TENS high-dose devices Intervention group IG the other group will utilize low-dose TENS devices Placebo group PG The baseline measurements will be performed and the patients will take the programmed device home for a duration of 8 weeks Then the patients will come back after four weeks 4W and after 8 weeks 8W for outcome assessment The primary outcome will be pain Secondary outcomes include nerve conduction and velocity vibration perception threshold quality of life Exploratory outcomes include gait assessment gait speed stride length double stance and gait steadiness and balance
Detailed Description: Chemotherapy and other cancer treatments can cause damage to the peripheral nerves mainly reflected in severe pain in the upper andor lower extremities Additional to pain cancer treatment may cause loss of balance which affects motor capacity and is a major cause of poor quality of life There are only minimally effective treatments for CIPN despite over 20 years of research Few recent studies have suggested that exercise intervention could be effective to restore numbness and motor capacity loss because of CIPN Unfortunately conventional rehabilitation programs however suffer from poor adherence and those programs for supervised settings have limitation of access for those who live in the remote areas eg rural area or could be too frail to travel after chemotherapy This raised a significant disparity for delivering an effective therapy for those who are living in remote areas or those who are too frail to travel Therefore will test Quell Transcutaneous Electrical Nerve Stimulation device developed by Neurometrix Inc Woburn MA USA to mitigate the associated symptoms caused by CIPN This device utilizes a wireless technology manageable through a smart phone application Quell App that also tracks symptom-status

The investigators institution Duncan Cancer Center McNair Campus Baylor College of Medicine St Lukes Houston Texas USA supervised by specialists in clinical and surgical oncology has a high volume of patients that present with CIPN Therefore the investigators believe that this institution is a suitable place to perform this sub-study The premise of this sub-study is that daily basis of TENS therapy could be effective to reduce pain reduce numbness and improve both motor-capacity and mobility performance leading to improve quality of life in those who suffer from CIPN and have limited access to health care

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None