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Completed

NCT Number: NCT04988321

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

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.

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Key information

Conditions

Diabetic Neuropathy, Painful Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prolonged continuous theta burst stimulation (pcTBS)

Procedure

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 3, 2021
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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