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RecruitingNCT07597161Updated Oct 29, 2026

Neuromodulation for Metabolic Dysfunction

An interventional study of Transcutaneous Spinal Cord Stimulation (tSCS) and Sham transcutaneous spinal cord stimulation (tSCS) in Spinal Cord Injuries (SCI) and Prediabetes / Type 2 Diabetes, sponsored by Rahul Sachdeva. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Rahul Sachdeva · Not applicable, Interventional, and Other

Updated Oct 29, 2026Now RecruitingFirst site in United States+8 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Spinal Cord Injuries (SCI)
  • Prediabetes / Type 2 Diabetes

Keywords

  • Spinal Cord Injury
  • Noninvasive Spinal Cord Stimulation
  • Type 2 Diabetes
03

In context

Spinal Cord Injuries

2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.

This study's planned enrollment of 120 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Rahul Sachdeva is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants must be at least 18 years of age and able to provide .

    • 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 , 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

Exclusion criteria

Exclusion Criteria:

  • 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., ).
    • 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Active transcutaneous spinal cord stimulation

    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.

    Device: Transcutaneous Spinal Cord Stimulation (tSCS)

  • Experimental
    Sham 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.

    Device: Sham transcutaneous spinal cord stimulation (tSCS)

Interventions

  • DeviceTranscutaneous Spinal Cord Stimulation (tSCS)

    Noninvasive Transcutaneous Spinal Cord Stimulation (tSCS)

  • DeviceSham transcutaneous spinal cord stimulation (tSCS)

    Inactive (sham) tSCS

06

What researchers measure

Primary outcomes

  1. Glucose and Insulin Levels with Oral Glucose Tolerance Test (OGTT)

    Enzyme-Linked Immunosorbent Assay

    Time frame: Weeks 1, 2, 7, 13, and 19

Secondary outcomes

  1. Continuous Glucose Monitoring

    Time in range

    Time frame: Baseline to 12 weeks

Other outcomes

  1. Change in glycosylated hemoglobin (HbA1c)

    Enzyme-Linked Immunosorbent Assay

    Time frame: Baseline and 12 weeks

  2. Change in metabolic profile

    Liquid Chromatography-Mass Spectrometry (LC-MS)

    Time frame: Baseline and 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Department of Physical Medicine and Rehabilitation-Research Suite
    Lexington, Kentucky 40504, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Raw, de-identified data will be submitted to appropriate repositories after completion of the study.

Supporting information: Study protocol, Informed consent form

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for May 2030, 43 months after the start.

Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 43 months is above that.

Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
May 12, 2026
First posted
May 19, 2026
StartActual
Oct 20, 2026
Primary completionEst.
May 31, 2030
CompletionEst.
Dec 2030
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Withheld→Recruiting
changed Oct 29, 2026
Sites
1 site added — first site in United States
Show site
  • Department of Physical Medicine and Rehabilitation-Research Suite · Lexington, United States
Oct 29, 2026
Start date
Set to Oct 20, 2026 (actual)
Oct 29, 2026
Primary completion
Set to May 31, 2030
Oct 29, 2026
Study completion
Set to Dec 2030
Oct 29, 2026
Eligibility
Revised
Oct 29, 2026
Interventions
Arms or interventions changed
Oct 29, 2026
Title
[Trial of device that is not approved or cleared by the U.S. FDA]→Neuromodulation for Metabolic Dysfunction
Oct 29, 2026
Sponsor
[Redacted]→Rahul Sachdeva
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    Withheld→Recruiting
    1 site added — first site in United States
    Show site
    • Department of Physical Medicine and Rehabilitation-Research Suite · Lexington, United States
    Start date Set to Oct 20, 2026 (now actual)
    Primary completion Set to May 31, 2030
    Study completion Set to Dec 2030
    Eligibility Revised
    Interventions Arms or interventions changed
    Sponsor [Redacted]→Rahul Sachdeva
    Title [Trial of device that is not approved or cleared by the U.S. FDA]→Neuromodulation for Metabolic Dysfunction
    + 9 other changes: index terms, registry dates, verification date, oversight details, description, conditions, design details, secondary outcomes and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07597161
Lead sponsor
Rahul Sachdeva
Responsible party
Rahul Sachdeva (Principal Investigator, University of Kentucky) — Sponsor-investigator
First posted
May 19, 2026
Start date
Oct 20, 2026
Primary completion
May 31, 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Oct 29, 2026

Study contacts

Rahul Sachedva, PhD
Contact
rsa327@uky.edu
859-257-4888
Vivek Pandey, PhD
Contact
vivek.pandey@uky.edu
8593233933

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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