Clinical trial NCT04988321: Theta Burst Brain Stimulation in Diabetic Neuropathy Patients With Neuropathic Pain: Investigating Neural Mechanisms
Official title: Theta Burst Brain Stimulation in Diabetic Neuropathy Patients With Neuropathic Pain: Investigating Neural Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathy, Painful
Keywords: transcranial magnetic stimulation
non-invasive brain stimulation
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) score
timeFrame: Baseline to the end of the procedure, about 2.25 hours
measure: Change in bodily and emotional perception of pain (BEEP) score
timeFrame: Baseline to the end of the procedure, about 2.25 hours
Secondary outcomes:
measure: Change in pain threshold - conditioned pain modulation (CPM)
timeFrame: Baseline to the end of the procedure, about 2.25 hours
measure: Change in pain threshold - Temporal Summation of Pain (TSP)
timeFrame: Baseline to the end of the procedure, about 2.25 hours
measure: Change in pain threshold - Offset Analgesia (OA)
timeFrame: Baseline to the end of the procedure, about 2.25 hours
measure: Change in cortical inhibition (CI)
timeFrame: Baseline to the end of the procedure, about 2.25 hours
measure: Change in corticospinal excitability (CE)
timeFrame: Baseline to the end of the procedure, about 2.25 hours
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
References: