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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06324344
• Other study ID #: H-50753-B
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: October 2, 2025

Study information

• Verified date: March 2024
• Source: Baylor College of Medicine
• Contact: Bijan Najafi, PhD
• Phone: 713-798-7538
• Email: bijan.najafi[@]bcm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2, 2025
• Est. primary completion date: October 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Neuropathy
• Pain
• Peripheral Nervous System Diseases

Intervention

Device:
• High-Dose TENS
high-dose TENS device delivers 1 hour of TENS therapy per session.
• Low-Dose TENS
low-dose TENS device delivers 6 minutes of TENS therapy per session.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	NeuroMetrix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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