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

NCT06324344 | Terminated Results FDA Device

• 1 other identifier: H-50753-B
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chemotherapy-induced Peripheral Neuropathy; Pain; Neuropathy

Keywords

Transcutaneous Electrical Nerve Stimulation; Quell

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Vibration Perception Threshold at 8 Weeks

  week 8

• Quality of Life at 8 Weeks

  week 8

Other Outcomes (5)

• Sural Nerve Conduction Velocity at 8 Weeks

  week 8

• Stride Time at 8 Weeks

  week 8

• Cadence at 8 Weeks

  week 8

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

High-Dose TENS DEVICE

high-dose TENS device delivers 1 hour of TENS therapy per session.

Also known as: High Dose TENS, Active

Intervention Group

Low-Dose TENS DEVICE

low-dose TENS device delivers 6 minutes of TENS therapy per session.

Also known as: Placebo

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• NeuroMetrix, Inc.: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Bijan Najafi
• Organization: Baylor College of Medicine

bijan.najafi@bcm.edu

7137987536

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Model Details: Participants who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned into two groups in a 1:1 ratio. One group will utilize high-dose TENS therapy (Intervention group, AG); the other group will utilize low-dose TENS devices (Placebo group, PG). Both groups will receive their respective devices at the initial visit (Baseline) and will be asked to return in 4 weeks and 8 weeks for follow-up assessment. Throughout this 8-week period the participants may receive follow-up phone calls assessing their compliance. All subjects will keep their active device after completion of the 8-week study.

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 21, 2024
• Study Start: October 2, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: December 30, 2024
• Results First Posted: December 30, 2024

Record last verified: 2024-12

Locations

US (1)