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

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Diabetic Neuropathy, Painful

Treatments: Procedure: Prolonged continuous theta burst stimulation (pcTBS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04988321

HM20021531

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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49 participants in 2 patient groups

Primary motor cortex (M1)

Active Comparator group

Description:

Stimulation of the M1

Treatment:

Procedure: Prolonged continuous theta burst stimulation (pcTBS)

Dorsolateral prefrontal cortex (DLPFC)

Active Comparator group

Description:

Stimulation of the DLPFC

Treatment:

Procedure: Prolonged continuous theta burst stimulation (pcTBS)