Theta Burst Brain Stimulation in Diabetic Neuropathy Patients With Neuropathic Pain: Investigating Neural Mechanisms
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Change in bodily and emotional perception of pain (BEEP) score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Dorsolateral prefrontal cortex (DLPFC)
Stimulation of the DLPFC
Intervention: Prolonged continuous theta burst stimulation (pcTBS) (Procedure)
Primary motor cortex (M1)
Stimulation of the M1
Intervention: Prolonged continuous theta burst stimulation (pcTBS) (Procedure)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- 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)
- Change in pain threshold - Offset Analgesia (OA)(Baseline to the end of the procedure, about 2.25 hours)
- 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)