NCT07597161Recruiting
Neuromodulation for Metabolic Dysfunction
Effects of Noninvasive Spinal Cord Neuromodulation on Metabolic Function
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
This study evaluates the use of noninvasive transcutaneous spinal cord stimulation (tSCS) to improve glucose regulation and metabolic function in individuals with and without spinal cord injury (SCI) across a spectrum of metabolic states, including no diabetes, prediabetes, and type 2 diabetes (T2D).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 12 May 2026
- Start date
- 20 Oct 2026
- Primary completion date
- 31 May 2030
- Lead sponsor
- Rahul Sachdeva
- Diseases
- Type 2 diabetes
- NCT number
- NCT07597161
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 20 Oct 2026 to the primary completion date, 31 May 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Unstable medical conditions (e.g., cardiac disease, active infections).
- Implanted devices (e.g., pacemakers, neurostimulators, ITB pumps).
- Change of medications that alter glucose metabolism (e.g., corticosteroids).
- Frequent, symptomatic hypoglycemia.
- Inability to tolerate stimulation procedures or complete study protocols.
- Diagnosis of Type 1 diabetes mellitus.
- Skin breakdown, eczema, or other dermatological conditions (e.g., psoriasis) affecting the skin at the site of electrodes placement.
- Females who are pregnant, breastfeeding, or intend to become pregnant.
- Cognitive impairments, social/psychological problems, or other comorbid conditions that, in the opinion of the Investigator, will preclude them from participation.
Who the study is looking for
- Participants must be at least 18 years of age and able to provide informed consent.
- Chronic spinal cord injury (at least 1 year post-injury) with neurological level of injury T6 or above, classified as AIS A-D, or able-bodied individuals without a history of spinal cord injury or neurological disorder
- Participants must meet criteria for normal glucose metabolism, prediabetes, or type 2 diabetes, determined using HbA1c, fasting plasma glucose, fasting insulin, or oral glucose tolerance testing (OGTT). Normal glucose metabolism is defined as HbA1c less than 5.7% and fasting plasma glucose less than or equal to 100 mg/dL. Impaired glucose metabolism (prediabetes or type 2 diabetes) will be identified by HbA1c greater than or equal to 5.7%, fasting plasma glucose greater than100 mg/dL (5.6 mmol/L), fasting insulin greater than 8.5-10 µIU/mL after at least 8 hours of fasting, or 2-hour plasma glucose greater than 140 mg/dL (7.8 mmol/L) during a standard OGTT performed using a 75 g anhydrous glucose load dissolved in water.
- Participants taking diabetes medications may be included if their medication regimen has been stable for at least 12 weeks before enrollment. This ensures observed metabolic changes are attributable to tSCS rather than recent medication adjustments. Medication use will be documented and included as a covariate in analyses to account for potential effects
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Physical Medicine and Rehabilitation-Research Suite Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.