NCT06292962

Brief Summary

The purpose of the study is to investigate the effects of non-invasive invasive vagal nerve stimulation on diabetic peripheral neuropathic pain in people with diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

December 24, 2023

Last Update Submit

April 19, 2024

Conditions

Diabetes MellitusDiabetic NeuropathiesType2diabetesNeuropathic Pain

Outcome Measures

Primary Outcomes (1)

  • Neuropathic pain scores

    Change in neuropathic pain scores assessed by validated questionnaire

    up to 24 weeks

Secondary Outcomes (1)

  • Quality of life score

    up to 24 weeks

Study Arms (2)

Group VTG

EXPERIMENTAL

Group VTG will receive active non-invasive transcutaneous vagal nerve stimulation (tVNS)

Device: non-invasive transcutaneous vagal nerve stimulation (tVNS)

Group STG

SHAM COMPARATOR

Group STG will receive Inactive sham stimulation

Device: Sham device

Interventions

non-invasive transcutaneous vagal nerve stimulation (tVNS)DEVICE

The device is used stimulate the vagus nerve

Also known as: tVNS device
Group VTG
Sham deviceDEVICE

Sham device that does not stimulate the vagus nerve

Also known as: SD
Group STG

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Type 2 diabetes mellitus \> 1 year
  • Patients experiencing neuropathic pain

You may not qualify if:

  • Patients with co-morbidities such as chronic pain from other conditions
  • Patients with serious complications of diabetes such as nephropathy and retinopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shifa Hospital

Lahore, Pakistan

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic NeuropathiesNeuralgia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
a randomized, double-blinded, sham-controlled, parallel group clinical trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 24, 2023

First Posted

March 5, 2024

Study Start

October 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 3, 2024

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)