Theta Burst Brain Stimulation in Diabetic Neuropathy Patients With Neuropathic Pain: Investigating Neural Mechanisms
1 other identifier
interventional
49
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2021
CompletedFirst Posted
Study publicly available on registry
August 3, 2021
CompletedStudy Start
First participant enrolled
September 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2022
CompletedJune 22, 2022
June 1, 2022
10 months
July 23, 2021
June 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) score
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
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 Outcomes (5)
Change in pain threshold - conditioned pain modulation (CPM)
Baseline to the end of the procedure, about 2.25 hours
Change in pain threshold - Temporal Summation of Pain (TSP)
Baseline to the end of the procedure, about 2.25 hours
Change in pain threshold - Offset Analgesia (OA)
Baseline to the end of the procedure, about 2.25 hours
Change in cortical inhibition (CI)
Baseline to the end of the procedure, about 2.25 hours
Change in corticospinal excitability (CE)
Baseline to the end of the procedure, about 2.25 hours
Study Arms (2)
Primary motor cortex (M1)
ACTIVE COMPARATORStimulation of the M1
Dorsolateral prefrontal cortex (DLPFC)
ACTIVE COMPARATORStimulation of the DLPFC
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Related Publications (1)
Thakkar B, Peterson CL, Acevedo EO. Single Session Effects of Prolonged Continuous Theta Burst Stimulation Targeting Two Brain Regions on Pain Perception in Patients with Painful Diabetic Neuropathy: A Preliminary Study. J Integr Neurosci. 2024 Mar 7;23(3):54. doi: 10.31083/j.jin2303054.
PMID: 38538225DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2021
First Posted
August 3, 2021
Study Start
September 3, 2021
Primary Completion
June 16, 2022
Study Completion
June 16, 2022
Last Updated
June 22, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share