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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04909593
Other study ID # A4091
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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