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: Recruiting
• 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 (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bijan Najafi, PhD; Phone Number: 713-798-7538; Email: bijan.najafi@bcm.edu
• Study Contact Backup: Name: Maria Noun, BS; Phone Number: 7137987538; Email: maria.noun@bcm.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
      • Contact: Maria Noun, BS; Phone Number: 713-798-7538; Email: maria.noun@bcm.edu
      • Contact: Bijan Najafi, PhD; Phone Number: 713-798-7536; Email: bijan.najafi@bcm.edu

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 will be assessed using the European Organization for Research and Treatment in Cancer (EORTC) Quality of Life Questionnaire (QLQ) - CIPN 20 Item. EORTC QLQ CIPN 20 is a 20-item questionnaire. The maximum value is 80, associated with the worst perceived impact of CIPN on the patient. The minimum value is 0, associated with the least perceived impact of CIPN on the patient.	Up to 8 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vibration perception threshold at 8 weeks from baseline	Change in Vibration Perception Threshold (VPT) will be assessed using the Neurothesiometer (Horwell Scientific Laboratory Supplies, UK) and VPT from Neuro Touch (Yostra Labs Bengaluru, Karnataka, India). Both devices are placed on the soles of the patient to detect the minimum amount of vibration needed to perceive the sensation.	Up to 8 Weeks
Change in sural nerve conduction velocity and amplitude at 8 weeks from baseline	Sural nerve conduction and amplitude will be evaluated using the DPNCheck® (Neurometrix, Woburn, MA, USA). This device is placed on the lateral portion of the lower extremity of the patient. The device sends non-invasive electrical stimulation through the sural nerve to obtain velocity and amplitude of conduction.	up to 8 Weeks
Changes in Quality of Life at 8 weeks from baseline	Quality of Life will be assessed using the European Organization for Research and Treatment in Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30). EORTC QLQC 30 (version 3.0) is a 30-item questionnaire designed to measure the quality of life in all cancer patients. This questionnaire includes functional (physical, role, cognitive, emotional, and social functioning) and Quality of Life scales (where a higher score indicates better health), and symptom scales (pain, fatigue, nausea and vomiting, pain, appetite loss, diarrhea, dyspnea, constipation, and insomnia) where a higher score indicates a higher level of symptom burden.	Up to 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in stride time at 8 weeks from baseline	Stride time will be measured utilizing wearable sensors (Delsys, Biosensics, MA) placed on both ankles, thighs and waist. The patient will be asked to walk for 30 feet in a normal pace (single task), followed by a normal pace and counting backwards from a random number (dual-task), and then walk faster but without jogging or running.	up to 8 weeks
Changes in cadence at 8 weeks from baseline	Cadence will be measured utilizing wearable sensors (Delsys, Biosensics, MA) placed on both ankles, thighs and waist. The patient will be asked to walk for 30 feet in a normal pace (single task), followed by a normal pace and counting backwards from a random number (dual-task), and then walk faster but without jogging or running.	up to 8 weeks
Changes in double-support phase at 8 weeks from baseline	Changes in double-support phase of gait will be measured utilizing wearable sensors (Delsys, Biosensics, MA) placed on both ankles, thighs and waist. The patient will be asked to walk for 30 feet in a normal pace (single task), followed by a normal pace and counting backwards from a random number (dual-task), and then walk faster but without jogging or running.	up to 8 weeks
Changes in Range of Motion (RoM) at 8 weeks from baseline	RoM will be measured utilizing wearable sensors (Delsys, Biosensics, MA) placed on both ankles, thighs and waist. The patient will be asked to stand for 10 seconds with their eyes opened, then with their eyes closed. RoM will be obtained from the hip and ankle motion.	up to 8 weeks

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 (Estimated): October 2, 2025
• Study Completion (Estimated): October 2, 2025

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, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 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