Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy Induced Peripheral Neuropathy (CIPN)

Transcutaneous Electrical Nerve Stimulation for Lower Extremity in Patients With Neurogenic Pain - A Proof Concept Randomized Clinical Trial

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 1:1 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.

Study Overview

• Status: Terminated
• Conditions: Pain; Neuropathy; Chemotherapy-induced Peripheral Neuropathy
• Intervention / Treatment: Device: High-Dose TENS; Device: Low-Dose TENS

Detailed Description

Chemotherapy and other cancer treatments can cause damage to the peripheral nerves mainly reflected in severe pain in the upper and/or 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 (e.g., 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 Luke's, 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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults ≥ 18 years old willing and able to participate in study.
• Able to use an app via smart phone.
• Patients with Chemotherapy Induced Peripheral Neuropathy (CIPN) grades II and III.
• Have undergone chemotherapy with a drug known to cause neurotoxicity.
• Have finished chemotherapy ≥1 month, and still experiences CIPN.

Exclusion Criteria:

• Pregnancy or Lactation.
• Nerve Block a week prior to enrollment.
• Peripheral Sensory Neuropathy Grade I and IV.
• Patients applying ointments to the lower extremities.
• Patients with electrical implanted devices such as pacemakers.
• Patients with lower extremity wounds/history of minor/major amputation.
• Planning to undergo any type of chemotherapy in the next 3 months.
• Neuropathy derived from uncontrolled Diabetes Mellitus.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Group; The intervention group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a high-dose TENS device for 8 weeks. The high-dose TENS device elicits 1 hour of TENS per session. Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis.	Device: High-Dose TENS; high-dose TENS device delivers 1 hour of TENS therapy per session.; Other Names: Active; High Dose TENS
Placebo Comparator: Placebo Group; The placebo group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a low-dose TENS device for 8 weeks. The low-dose TENS device is identical to the high-dose TENS device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis.	Device: Low-Dose TENS; low-dose TENS device delivers 6 minutes of TENS therapy per session.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Level at 8 Weeks From Baseline	Pain was assessed using Item 9 of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3), which ranges from 1 ("not at all" experiencing pain) to 4 ("very much" experiencing pain). The percentage change from baseline to week 8 was reported, with negative values indicating a reduction in pain and positive values indicating an increase in pain.	baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vibration Perception Threshold at 8 Weeks	Change in Vibration Perception Threshold (VPT) will be assessed using the Neuro Touch device (Yostra Labs, Bengaluru, Karnataka, India). Measurements will be taken on the big toe of the participants' left and right feet to determine the minimum vibration intensity required to perceive sensation. VPT values range from 0 to 50 volts, with higher values indicating greater numbness.	week 8
Quality of Life at 8 Weeks	Quality of Life will be assessed using the European Organization for Research and Treatment in Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQC 30 ). It consists of 30 items divided into three main subscales: functional, symptom, and global health. Each subscale provides a comprehensive view of the patient's health and well-being. The Functional Scale measures physical, role, emotional, cognitive, and social functioning, with scores ranging from 0 to 100; higher scores indicate better functioning. The Symptom Scale evaluates cancer-related symptoms like fatigue, pain, and nausea, where higher scores (0-100) indicate greater symptom severity. The Global Health Scale assesses overall quality of life and general health, also scored from 0 to 100, with higher scores reflecting better health and well-being. These subscales provide critical insights for evaluating the impact of cancer and its treatment on patients.	week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sural Nerve Conduction Velocity at 8 Weeks	Sural nerve conduction velocity will be evaluated using the DPNCheck® device (Neurometrix, Woburn, MA, USA). The device is placed on the lateral portion of the patient's lower extremity and sends non-invasive electrical stimulation through the sural nerve to measure conduction velocity and amplitude. Conduction velocity is measured in meters per second (m/s), with normal values being greater than 40 m/s, while values below 40 m/s indicate slowed nerve signal transmission.	week 8
Stride Time at 8 Weeks	Stride time will be measured utilizing wearable sensors (LEGSys, Biosensics, MA) placed on both ankles, thighs and waist. The patient will be asked to walk for 30 feet in a normal pace. The unit is second and higher values indicate slower gait.	week 8
Cadence at 8 Weeks	Cadence will be measured utilizing wearable sensors (LegSys, Biosensics, MA) placed on both ankles, thighs and waist. The patient will be asked to walk for 30 feet in a normal pace. The number is steps per minute, higher values indicate faster speed.	week 8
Double-support Phase at 8 Weeks	The double-support phase of gait will be measured utilizing wearable sensors (LEGSys, Biosensics, MA) placed on both ankles, thighs and waist. The patient will be asked to walk for 30 feet in a normal pace. The percentage of time the patient spends in the double support phase during the gait cycle will be recorded. Higher value indicates worst gait performance	week 8
Balance at 8 Weeks	Balance will be measured utilizing wearable sensors (BalaneSense, Biosensics, MA) placed on both ankles, thighs and waist. The patient will be asked to stand for 30 seconds with their eyes opened, then with their eyes closed. Center of Mass sway Area will be obtained from the hip and ankle motion. The unit is cm2 and higher value indicates poor balance. The center of mass sway was reported for eyes-closed condition.	week 8

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: NeuroMetrix, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Transcutaneous Electrical Nerve Stimulation; Quell
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: H-50753-B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes