Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial

Chronic Pain Clinical Trial

— AIM  

Official title:

Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial: The AIM Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04909593
• Other study ID #: A4091
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2021
• Est. completion date: July 2024

Study information

• Verified date: June 2024
• Source: Boston Scientific Corporation
• Contact: Gerard Herro
• Phone: 855-213-9890
• Email: BSNClinicalTrials[@]bsci.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to assess the feasibility of using information extracted from physiologic signals to automatically adjust stimulation in patients undergoing Spinal Cord Stimulation (SCS).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Study candidate is undergoing a temporary SCS trial of commercially approved BSC neurostimulator system, per local directions for use (DFU).

• Subject signed a valid, EC/IRB-approved informed consent form.

• Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law when written informed consent is obtained.

• In the clinician best judgment, subject is able to distinguishably describe quality and location of sensation and pain.

Key Exclusion Criteria:

• Subject meets any contraindication in BSC neurostimulation system local DFU.

• Investigator-suspected gross lead migration during the SCS trial period which may preclude the study candidate from receiving adequate SCS therapy.

• Subject is currently diagnosed with cognitive impairment, or exhibits any characteristic, that in the clinician's best judgement would limit study candidate's ability to assess and report sensation information.

• Subject is currently diagnosed with a physical impairment, or exhibits a condition that would limit study candidate's ability to complete study assessments.

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Intractable Pain
• Low Back Pain
• Neuralgia
• Pain, Back
• Pain, Intractable
• Pain, Neuropathic

Intervention

Device:
• Spinal Cord Stimulation
Spinal cord stimulation at varied electrode, pulse width, frequency and amplitude parameters

Locations

Country	Name	City	State
United States	PCPMG Clinical Research Unit, LLC	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perception Threshold	Percent change in perception threshold from sitting to standing	up to 15 days post-screening