Evaluating the Impact of Vagus Nerve Stimulation on Diabetic Peripheral Neuropathic Pain

NCT ID: NCT06292962

Last Updated: 2024-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-03-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study is a randomized, double-blinded, sham-controlled, parallel-group clinical trial, which will include participants with diabetic peripheral neuropathic pain.

Participants are randomized to receive either active non-invasive transcutaneous vagal nerve stimulation (tVNS) or inactive sham stimulation.

The study will investigate the effects of short-term, high-intensity tVNS treatment on peripheral pain.

The primary outcome is subjective patient evaluation of pain symptoms by the use of validated questionnaires.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus Diabetic Neuropathies Type2diabetes Neuropathic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
a randomized, double-blinded, sham-controlled, parallel group clinical trial

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group VTG

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

Group Type EXPERIMENTAL

non-invasive transcutaneous vagal nerve stimulation (tVNS)

Intervention Type DEVICE

The device is used stimulate the vagus nerve

Group STG

Group STG will receive Inactive sham stimulation

Group Type SHAM_COMPARATOR

Sham device

Intervention Type DEVICE

Sham device that does not stimulate the vagus nerve

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

non-invasive transcutaneous vagal nerve stimulation (tVNS)

The device is used stimulate the vagus nerve

Intervention Type DEVICE

Sham device

Sham device that does not stimulate the vagus nerve

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

tVNS device SD

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Patients with co-morbidities such as chronic pain from other conditions
* Patients with serious complications of diabetes such as nephropathy and retinopathy
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Al Ain University

UNKNOWN

Sponsor Role collaborator

Saima Abass Tahammal

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Saima Abass Tahammal

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shifa Hospital

Lahore, , Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SH-34988389

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nociceptive Pain Fiber Response
NCT02696070 COMPLETED NA