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

June 21, 2022 updated by: Virginia Commonwealth University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The proposed brain stimulation technique in this study is an investigational procedure that has not been approved by the U.S. FDA for treating pain linked to diabetic neuropathy, but it has been approved to treat depression. The study will use surveys to monitor how participant's body changes as their understanding of their pain experience changes. Participants will be randomized (like the flip of a coin) to receive brain stimulation at one of two brain regions which are involved in the processing and understanding of the pain experience.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with type II Diabetes Mellitus.
  • Age 18-75 years.
  • Diagnosed by a Physician with diabetic neuropathy/ distal symmetric polyneuropathy/ diabetic polyneuropathy.
  • Patients under physician care at Virginia Commonwealth University Health Systems in the Neurology Clinic/ Neurology Department and the Endocrinology Clinic
  • Neuropathic pain for at least 3 months.
  • Neuropathic pain signs and symptoms identified using Pain DETECT questionnaire.
  • Current pain score ≥3 or higher (0='no pain' and 10='worst possible pain').
  • Pain Medication dosage stable for at least 4 weeks

Exclusion Criteria:

  • Non-neuropathic chronic pain
  • Another concurrent cause of neuropathic pain
  • Any history of epilepsy, drug-resistant migraine, and/or any presence of ferromagnetic implant, cardiac pacemakers, implanted insulin pumps, neurostimulators, cochlear implants and surgical clips or medical pumps.
  • Limited English proficiency
  • Pregnant patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Primary motor cortex (M1)
Stimulation of the M1
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.
ACTIVE_COMPARATOR: Dorsolateral prefrontal cortex (DLPFC)
Stimulation of the DLPFC
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) score
Time Frame: Baseline to the end of the procedure, about 2.25 hours
The QOL-DN is questionnaire is an instrument to assess quality of life in patients with diabetic polyneuropathy. It is comprised of 35 items and yields a Total QOL score.
Baseline to the end of the procedure, about 2.25 hours
Change in bodily and emotional perception of pain (BEEP) score
Time Frame: Baseline to the end of the procedure, about 2.25 hours
The BEEP questionnaire is a self-report questionnaire measuring the impact of chronic pain on daily life. It has 23 items on a 0-5 Likert scale that assesses three pain dimensions, namely the emotional reaction to pain, the limitations to daily life caused by pain and the interference caused by pain in personal and social functioning. Responses are summed to yield a single BEEP score.
Baseline to the end of the procedure, about 2.25 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in pain threshold - conditioned pain modulation (CPM)
Time Frame: Baseline to the end of the procedure, about 2.25 hours
To measure CPM, brief amounts of slight pressure using a handheld pressure device will be applied to a location either on the forearm or leg where the patient reports a current absence of pain. An average index percent ratio will be calculated from the pressure device in kilopascals at which participants report the pressure was first perceived as painful during a baseline assessment and during an assessment when the participant's contralateral hand was placed in cold water. Change will be measured by subtracting CPM scores before and after the active procedure.
Baseline to the end of the procedure, about 2.25 hours
Change in pain threshold - Temporal Summation of Pain (TSP)
Time Frame: Baseline to the end of the procedure, about 2.25 hours
To measure TSP, the same pressure using a handheld pressure device that was perceived as first painful will be applied to a location either on the forearm or leg where the patient reports a current absence of pain. This pressure will be applied repeatedly applied 10 times and participants will be asked to report their pain on a 0-10 scale where 0 is no pain and 10 is worst pain imaginable. Change will be measured by subtracting TSP scores before and after the active procedure.
Baseline to the end of the procedure, about 2.25 hours
Change in pain threshold - Offset Analgesia (OA)
Time Frame: Baseline to the end of the procedure, about 2.25 hours
A Velcro strap tied to participants forearm connected to a device that transmits heat will be used to measure OA. Three different temperatures of mild heat will be applied. Participants will use a visual analog scale (VAS, no heat 0- extreme heat 10) to rate the intensity of the heat stimulus at each temperature. Minimal VAS ratings at the highest temperature will be subtracted from maximal VAS ratings at the lowest temperature to yield OA value. Change will be measured by subtracting OA values before and after the active procedure.
Baseline to the end of the procedure, about 2.25 hours
Change in cortical inhibition (CI)
Time Frame: Baseline to the end of the procedure, about 2.25 hours
The amplitude the motor evoked potentials (MEPS) from two simultaneous pulses will be used to determine level of cortical inhibition.
Baseline to the end of the procedure, about 2.25 hours
Change in corticospinal excitability (CE)
Time Frame: Baseline to the end of the procedure, about 2.25 hours
The amplitude the motor evoked potentials (MEPS) from a single pulse will be used to determine level of corticomotor excitability
Baseline to the end of the procedure, about 2.25 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 16, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 16, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HM20021531

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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