Spinal Cord Stimulation Through the Skin for Blood Sugar and Metabolism
Tests skin-surface spinal cord stimulation on blood sugar control, with or without spinal cord injury.
Key facts
- Who runs it
- Rahul Sachdeva
- Where
- Lexington, United StatesSee the site
- Trial code
- Registry title
- Neuromodulation for Metabolic Dysfunction
- Status
- Recruiting
- People taking part
- 120 people, planned
- Started
- 20 Oct 2026
- Expected to end
- Dec 2030
- Type of study
- Interventional, 2 groups
- Treatments tested
- Transcutaneous Spinal Cord Stimulation (tSCS)
- Sham transcutaneous spinal cord stimulation (tSCS)
- Record updated
- 29 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with or without a spinal cord injury, with normal blood sugar, prediabetes or type 2 diabetes, to test a skin-surface spinal cord stimulation on blood sugar control.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Either a long-term spinal cord injury (at least 1 year ago, level T6 or above, AIS A-D) or no spinal cord injury or neurological disorder. Blood sugar must be normal, prediabetes or type 2 diabetes.
- Earlier treatment
- People taking diabetes medicines can join if the dose has been stable for at least 12 weeks before enrolment.
- Biomarker or test result
- Blood sugar tests (HbA1c, fasting glucose, fasting insulin or oral glucose tolerance test) show normal blood sugar, prediabetes or type 2 diabetes.
Main reasons for not taking part
- Unstable medical conditions, such as heart disease or active infections
- Implanted devices, such as pacemakers, neurostimulators or ITB pumps
- Type 1 diabetes
- Frequent hypoglycemia with symptoms
- Pregnant, breastfeeding or planning to become pregnant
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in United States
- Department of Physical Medicine and Rehabilitation-Research SuiteLexington, United StatesContact: Vivek Pandey, PhDTaking people
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- Active transcutaneous spinal cord stimulationTreatment being tested
Individuals with and without spinal cord injury, including those without diabetes, with prediabetes, or with type 2 diabetes (T2D), for a total of six groups.
Treatment: Transcutaneous Spinal Cord Stimulation (tSCS)
- Sham tSCSTreatment being tested
Individuals with and without spinal cord injury, including those without diabetes, with prediabetes, or with type 2 diabetes (T2D), for a total of six groups.
Treatment: Sham transcutaneous spinal cord stimulation (tSCS)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effects of Noninvasive Spinal Cord Neuromodulation on Metabolic Function
- Plain-language title
- Spinal Cord Stimulation Through the Skin for Blood Sugar and MetabolismGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 29 October 2026