Spinal Cord Injuries (SCI)NCT07597161
Neuromodulation for Metabolic Dysfunction
A study testing Transcutaneous Spinal Cord Stimulation (tSCS) in people with Spinal Cord Injuries (SCI) and Prediabetes / Type 2 Diabetes, run by Rahul Sachdeva at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries (SCI), Prediabetes / Type 2 Diabetes
- What is being tested?
- Transcutaneous Spinal Cord Stimulation (tSCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Department of Physical Medicine and Rehabilitation-Research Suite
Lexington, Kentucky, 40504
Vivek Pandey, PhD, 8593233933, vivek.pandey@uky.edu
About this study
Official title: Effects of Noninvasive Spinal Cord Neuromodulation on Metabolic Function
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).
Read the detailed description
Individuals with SCI are at increased risk of metabolic dysfunction due to reduced muscle mass, altered metabolism, autonomic dysfunction, and limited ability to engage in physical activity. However, metabolic impairment also affects able-bodied individuals, and current treatment strategies for glucose dysregulation are often insufficient or associated with complications. This highlights the need for safe, noninvasive interventions that target underlying physiological mechanisms. This pilot study will evaluate both the acute and chronic effects of tSCS on glucose metabolism. Primary outcomes include glucose and insulin responses during OGTT and changes in HbA1c, with secondary outcomes including insulin sensitivity and metabolic biomarkers.
- Being tested
- Transcutaneous Spinal Cord Stimulation (tSCS), Sham transcutaneous spinal cord stimulation (tSCS)
- Keywords
- Spinal Cord Injury, Noninvasive Spinal Cord Stimulation, Type 2 Diabetes
- Medical subject headings
- Spinal Cord Injuries, Prediabetic State, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Spinal Cord Stimulation (tSCS)Device
Noninvasive Transcutaneous Spinal Cord Stimulation (tSCS)
Sham transcutaneous spinal cord stimulation (tSCS)Device
Inactive (sham) tSCS
| Study group | Role | What they receive |
|---|---|---|
| Active transcutaneous spinal cord stimulation | Experimental | 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. Receives: Device: Transcutaneous Spinal Cord Stimulation (tSCS) |
| Sham tSCS | Experimental | 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. Receives: Device: Sham transcutaneous spinal cord stimulation (tSCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose and Insulin Levels with Oral Glucose Tolerance Test (OGTT)
Enzyme-Linked Immunosorbent Assay
Measured: Weeks 1, 2, 7, 13, and 19
Secondary outcomes (1)
Continuous Glucose Monitoring
Time in range
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start20 Oct 2026
- Primary completion31 May 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rahul Sachdeva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rahul Sachdeva, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597161
- Sponsor's protocol ID
- 106025
- Status last verified
- Oct 2026
- First submitted
- 12 May 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Raw, de-identified data will be submitted to appropriate repositories after completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Noninvasive Spinal Cord Neuromodulation on Metabolic Function
- ClinicalTrials.gov ID
- NCT07597161
- Acronym / sponsor ID
- 106025
- Keywords
- Spinal Cord Injury, Noninvasive Spinal Cord Stimulation, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rahul SachdevaUniversity, hospital or other
- Study start
- 20 Oct 2026 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Individuals with SCI are at increased risk of metabolic dysfunction due to reduced muscle mass, altered metabolism, autonomic dysfunction, and limited ability to engage in physical activity. However, metabolic impairment also affects able-bodied individuals, and current treatment strategies for glucose dysregulation are often insufficient or associated with complications. This highlights the need for safe, noninvasive interventions that target underlying physiological mechanisms. This pilot study will evaluate both the acute and chronic effects of tSCS on glucose metabolism. Primary outcomes include glucose and insulin responses during OGTT and changes in HbA1c, with secondary outcomes including insulin sensitivity and metabolic biomarkers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active transcutaneous spinal cord stimulation | Experimental | Device: Transcutaneous Spinal Cord Stimulation (tSCS)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. |
| Sham tSCS | Experimental | Device: Sham transcutaneous spinal cord stimulation (tSCS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must be at least 18 years of age and able to provide informed consent.
Key exclusion criteria (9 listed)
- Unstable medical conditions (e.g., cardiac disease, active infections).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Spinal Cord Stimulation (tSCS)Noninvasive Transcutaneous Spinal Cord Stimulation (tSCS) | Device | Active transcutaneous spinal cord stimulation |
| Sham transcutaneous spinal cord stimulation (tSCS)Inactive (sham) tSCS | Device | Sham tSCS |
Primary outcome
Glucose and Insulin Levels with Oral Glucose Tolerance Test (OGTT)
Time frame: Weeks 1, 2, 7, 13, and 19
Enzyme-Linked Immunosorbent Assay
1 secondary outcome
Continuous Glucose Monitoring
Time frame: Baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes. Raw, de-identified data will be submitted to appropriate repositories after completion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Spinal Cord Stimulation (tSCS) in people with Spinal Cord Injuries (SCI) and Prediabetes / Type 2 Diabetes, run by Rahul Sachdeva at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rahul Sachedva, PhD (859-257-4888, rsa327@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose and Insulin Levels with Oral Glucose Tolerance Test (OGTT) (time frame: Weeks 1, 2, 7, 13, and 19). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.