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Theta Burst Brain Stimulation in Diabetic Neuropathy Patients With Neuropathic Pain: Investigating Neural Mechanisms

NCT04988321 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2022-06-22

No results posted yet for this study

Summary

The purpose of the study is to determine the effects of a newer form of non-invasive brain stimulation (called transcranial magnetic stimulation or TMS) as a treatment in patients with painful diabetic neuropathy to examine its effects on their understanding of their pain experience.

Conditions

  • Diabetic Neuropathy, Painful

Interventions

PROCEDURE

Prolonged continuous theta burst stimulation (pcTBS)

Non-invasive brain stimulation (transcranial magnetic stimulation or TMS) which consists of a stimulating coil being held over the head. When this coil delivers a painless magnetic pulse, it feels like a quick, light tap on the head. Two different coils will be used to perform TMS. One coil will be used to determine stimulation parameters for the pcTBS protocol. The second coil will be used to implement pcTBS, which is a repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on the head. Participants will receive two procedures during one session, one with active stimulation and one with inactive stimulation.

Sponsors & Collaborators

  • Virginia Commonwealth University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-03
Primary Completion
2022-06-16
Completion
2022-06-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04988321 on ClinicalTrials.gov