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Behavioural Intervention
Scrambler Therapy for Peripheral Neuropathy
N/A
Recruiting
Led By Salahadin Abdi, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who have CIPN associated with at least moderate symptoms of pain (≥4 on a 0-10 scale) or neuropathy
Patients who have had cancer and are not being actively treated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial will investigate whether Scrambler therapy is effective in reducing pain and chemotherapy-induced peripheral neuropathy in adolescents and young adults with cancer, as well as the impact of this therapy on physical functioning and quality of life.
Who is the study for?
This trial is for English-speaking adolescents and young adults aged 15-39 who have had cancer, are not currently in active treatment, and suffer from moderate to severe chemotherapy-induced painful peripheral neuropathy (pain level ≥4). They must be able to complete questionnaires with or without assistance. Those with mobility issues, brain or bone metastases affecting movement, prior Scrambler Therapy, certain implants, epilepsy, skin damage where electrodes would go, or other pain conditions are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness of Scrambler Therapy on reducing pain from chemotherapy-induced peripheral neuropathy and improving physical function and quality of life. Participants will be randomly assigned to either receive immediate therapy or placed on a waitlist (control group) in this prospective randomized controlled trial.See study design
What are the potential side effects?
While specific side effects of Scrambler Therapy aren't detailed here, it's generally considered non-invasive with minimal risks. Potential discomfort may arise from electrode placement on the skin depending on individual sensitivity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience moderate to severe pain or neuropathy from chemotherapy.
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I had cancer but am not currently receiving treatment.
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I am between 15 and 39 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The European Organization for Research and Treatment of Cancer ( EORTC-QLQ C30)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Waitlist ST (Scrambler Therapy)Experimental Treatment1 Intervention
Participant will start ST (Scrambler Therapy) treatment about 4 weeks after your Baseline Visit.
Group II: Immediate St (Scrambler Therapy)Experimental Treatment1 Intervention
Participant will start ST (Scrambler Therapy) treatment right away.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Peripheral neuropathy treatments aim to alleviate pain and improve quality of life by targeting different mechanisms of pain signal transmission. Common treatments include medications like gabapentin and tricyclic antidepressants, which modulate neurotransmitter activity to reduce pain perception.
Topical treatments, such as lidocaine patches, provide localized pain relief by blocking sodium channels in nerve cells, thereby inhibiting pain signal transmission. Scrambler Therapy (ST) is an innovative approach that uses electrical stimulation to interfere with pain signal transmission, effectively 'scrambling' the pain messages sent to the brain.
This method is particularly relevant for peripheral neuropathy patients as it offers a non-pharmacological option that can reduce reliance on medications and their associated side effects.
The diagnostic workup of patients with neuropathic pain.
The diagnostic workup of patients with neuropathic pain.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,992 Previous Clinical Trials
1,792,617 Total Patients Enrolled
4 Trials studying Peripheral Neuropathy
197 Patients Enrolled for Peripheral Neuropathy
National Cancer Institute (NCI)NIH
13,719 Previous Clinical Trials
40,963,520 Total Patients Enrolled
13 Trials studying Peripheral Neuropathy
1,435 Patients Enrolled for Peripheral Neuropathy
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,408 Total Patients Enrolled
1 Trials studying Peripheral Neuropathy
301 Patients Enrolled for Peripheral Neuropathy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience moderate to severe pain or neuropathy from chemotherapy.I can speak English and fill out questionnaires myself or with help.I have skin damage where electrodes were placed, have had ST treatment, or take pain meds for reasons other than CIPN.I am between 15 and 39 years old.I have cancer but am not currently receiving treatment.I experience moderate to severe pain or neuropathy from chemotherapy.My cancer has spread to my bones or brain, affecting how I walk and balance.I need help to walk or stand.I have a history of chronic pain, whether nerve-related or not.I had cancer but am not currently receiving treatment.I am between 15 and 39 years old.I can speak English and fill out forms alone or with help.I have cancer but am not currently receiving treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Immediate St (Scrambler Therapy)
- Group 2: Waitlist ST (Scrambler Therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Peripheral Neuropathy Patient Testimony for trial: Trial Name: NCT05357469 — N/A
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