Diabetic Neuropathy, Painful Clinical Trial
Official title:
Theta Burst Brain Stimulation in Diabetic Neuropathy Patients With Neuropathic Pain: Investigating Neural Mechanisms
Verified date | June 2022 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 49 |
Est. completion date | June 16, 2022 |
Est. primary completion date | June 16, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Change in pain threshold - conditioned pain modulation (CPM) | 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 | |
Secondary | Change in pain threshold - Temporal Summation of Pain (TSP) | 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 | |
Secondary | Change in pain threshold - Offset Analgesia (OA) | 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 | |
Secondary | Change in cortical inhibition (CI) | 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 | |
Secondary | Change in corticospinal excitability (CE) | 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 |
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