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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06287736
Other study ID # 2023H0386
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date December 31, 2026

Study information

Verified date February 2024
Source Ohio State University
Contact Destiny West
Phone 614-366-7822
Email Destiny.West@osumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective randomized control trial. Participants enrolled into the study will be randomized into one of three groups, two of which are treatment groups and the third is a control group. A time course of measurements before and after spinal cord stimulation (SCS) treatment (where applicable) will assess pain, DPN severity, small fiber nerve activity, and metabolic health markers.


Description:

Peripheral neuropathy (PN) is caused by diabetes, aging, chemotherapy, and over 30 other conditions, and impacts more than 30 million patients in the US alone. Diabetes is the number one cause of peripheral neuropathy, and more than half of patients with diabetes will eventually develop diabetic peripheral neuropathy (DPN), a complex set of symptoms including pain, numbness, tingling, and burning. Spinal cord stimulation (SCS) is an approved intervention for the treatment of chronic pain, including DPN. Spinal cord stimulation has had FDA approval for the treatment of painful DPN since 2015. This study is being done to learn more about the diagnosis of DPN and treatment of DPN with SCS.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Over 18 years old - Diagnosis of diabetic peripheral neuropathy refractory to treatment with gabapentin or pregabalin and at least 1 other class of analgesic - Diagnosis of medically refractory pain secondary to diabetic neuropathy - Presence of pain for 12 months - Lower limb pain intensity score =4 on a visual analog scale - DN4 =4 - Pass pre-operative neuropsychological assessment (surgical group only) - Capable of providing informed consent Exclusion Criteria: - Severe medical comorbidities that, in the opinion of the surgeon, exclude the patient from surgical intervention - Spinal disease with severe spinal stenosis or spinal cord compression in the region of the proposed spinal cord stimulator lead placement - Coagulopathy that cannot be corrected - Unable to discontinue blood thinning medications - Hemoglobin A1c level greater than 10 - Presence of systemic infection - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Spinal Cord Stimulator Implantation (SCS)
Spinal cord stimulator implantation is broken up into two parts. The first part involves placement of temporary SCS leads for a one-week trial. If the participants respond favorably to the SCS, then they will undergo the second part and the device is implanted

Locations

Country Name City State
United States The Ohio State University Wexner Medical Center Columbus Ohio

Sponsors (2)

Lead Sponsor Collaborator
Ohio State University Neuright, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Pain level change in Visual analog pain scale (VAS). The VAS endpoints range from 'no pain at all' to 'pain as bad as it could be' 18 months post baseline
Primary Change in Diabetic Peripheral Neuropathy (DPN) Pain using the Neuropathic pain diagnostic questionnaire (DN4) Neuropathic Pain Diagnostic "Douleur Neuropathique 4" questionnaire (DN4) is a screening questionnaire to help identify neuropathic pain (NP) in clinical practice and research. It is a clinican-administered questionnaire consisting of 10 items.The first 7 symptoms items are scored by interviewing the patient, and the 3 remaining items are scored by means of clinical examination. The scores are added and a score of 4 or more out of 10 is suggestive of neuropathic pain 18 months post baseline
Primary Change in PROMIS quality of life in relation to pain level Change in patient-reported outcomes measurement (PROMIS 29) 18 months post baseline
Secondary change in neuropathic symptoms using Michigan Neuropathy Screening instrument change in Michigan Neuropathy Screening instrument (MNSI). The MNSI is designed to be used in the outpatient setting. The MNSI is broken up into 2 parts. The first part consists of 15 yes/no questions on foot sensation. The highest score is 13, and the higher the score indicates more neuropathic symptoms. 18 months post baseline
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