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Device
Automated Spinal Cord Stimulation for Chronic Pain (AIM Trial)
N/A
Recruiting
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 days post-screening
Awards & highlights
AIM Trial Summary
This trial will test whether a computer can be used to automatically adjust stimulation given to patients with Spinal Cord Stimulation, in order to improve the treatment.
Who is the study for?
This trial is for adults who can clearly describe their pain and sensation, are undergoing a temporary Spinal Cord Stimulation (SCS) trial with an approved BSC neurostimulator system, and have signed informed consent. It's not for those with contraindications to BSC systems, suspected lead migration issues during the SCS trial, cognitive impairments that affect sensation reporting, or physical conditions preventing completion of study assessments.Check my eligibility
What is being tested?
The study aims to test if physiologic signals can be used to automatically adjust stimulation levels in patients receiving Spinal Cord Stimulation (SCS) therapy for various chronic pain conditions like neuropathic and lower back pain.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical SCS-related side effects may include discomfort at the implant site, unwanted changes in stimulation felt by the patient, potential lead migration causing varied sensations or loss of therapy effect.
AIM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 15 days post-screening
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 days post-screening
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Perception Threshold
Side effects data
From 2019 Phase 4 trial • 30 Patients • NCT0328441110%
Device stimulation issue
3%
Inadequate analgesia
3%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Spinal Cord Stimulation
AIM Trial Design
1Treatment groups
Experimental Treatment
Group I: Spinal Cord StimulationExperimental Treatment1 Intervention
SCS trial systems including external trial stimulators, lead(s)/extensions(s), and operating room (OR) cable(s)/extender(s) and optional sensor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spinal Cord Stimulation
2020
Completed Phase 4
~90
Find a Location
Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor
720 Previous Clinical Trials
932,997 Total Patients Enrolled
32 Trials studying Chronic Pain
65,144 Patients Enrolled for Chronic Pain
Roshini JainStudy DirectorBoston Scientific Neuromodulation Corporation
30 Previous Clinical Trials
26,270 Total Patients Enrolled
12 Trials studying Chronic Pain
11,483 Patients Enrolled for Chronic Pain
Kristen Lechleiter, M.S.Study DirectorBoston Scientific Neuromodulation Corporation
1 Previous Clinical Trials
17 Total Patients Enrolled
1 Trials studying Chronic Pain
17 Patients Enrolled for Chronic Pain
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Eligibility Criteria:
This trial includes the following eligibility criteria:- The doctor thinks the implanted lead for spinal cord stimulation might have moved a lot, which could make it hard for the person to get the right treatment.I am currently trying out a specific approved neurostimulator system.You have a medical condition that makes it unsafe for you to use the BSC neurostimulation system.The doctor believes you can clearly explain where and how you feel sensations and pain.I am over 18 (or the legal age in my country) and can give informed consent.I have a physical condition that may prevent me from completing study tasks.
Research Study Groups:
This trial has the following groups:- Group 1: Spinal Cord Stimulation
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.
Chronic Pain Patient Testimony for trial: Trial Name: NCT04909593 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being monitored for this research?
"Affirmative. Clinicaltrials.gov data suggests that this experiment, which was initially listed on May 24th 2021, is actively searching for participants. The research team aims to enroll 25 individuals from 1 location."
Answered by AI
Are individuals currently able to join this experiment?
"Clinicaltrials.gov states that this medical trial is actively recruiting patients - the original posting was on May 24th 2021, and the most recent amendment to it occurred on November 2nd 2022."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
Tennessee
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
PCPMG Clinical Research Unit, LLC
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have tried many drugs and medications and exercises and nothing has been able to alleviate my pain. I’ve been dealing with it for years… been to many different chiropractors as well. I feel great when I leave but the next day I am back to feeling the same.
PatientReceived 1 prior treatment
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