rTMS on Diabetic Peripheral Neuropathic Pain

Min Cheol Chang

Status: Unknown

Conditions: Diabetic Peripheral Neuropathic Pain

Treatments: Device: repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04833660

YUMC 2021-03-043

Details and patient eligibility

About

Background: Approximately half of the patients with long-standing diabetes are known to have diabetic peripheral neuropathy (DPN). Pain from DPN deteriorates the quality of life and hinders daily life activities.

Objectives: This study aimed to evaluate the effect of high-frequency (10 Hz) repetitive transcranial magnetic stimulation (rTMS) on the left primary motor cortex (M1) for neuropathic pain in the lower extremities due to DPN.

Methods: In this randomized trial, 22 patients with DPN will randomly assign to the rTMS group (10 Hz stimulation, five sessions) or the sham group. A numeric rating scale (NRS) will use to measure pain intensity before treatment and after 1 day and 1 week of the treatment. Physical and mental health status will evaluate using the Short Form 36-Item Health Survey (SF-36), comprising two subscales (physical and mental component scores [PCSs and MCSs]), at 1-week post-treatment.

Enrollment: 22 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diabetes
• neuropathic pain (stocking glove distribution) of a numeric rating scale (NRS) score of ≥3 (where 0 indicates no pain and 10 indicates the most intense pain imaginable) in the lower extremities
• pain duration of ≥3 months
• age between 21 and 80 years

Exclusion criteria

• presence of contraindications for TMS, such as a history of epileptic seizure, presence of metal in the skull, and presence of a cardiac pacemaker.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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22 participants in 2 patient groups

rTMS group

Experimental group

Description:

Each patient will receive five consecutive sessions (Monday to Friday for 1 week). Patients in the rTMS group will administer rTMS over the optimal scalp site at 10 Hz, with an intensity of 90% of the MT and a duration of 5 seconds, for a total of 20 trains separated by 55-second intertrain pauses (a total of 1,000 pulses). The coil will be placed tangentially to the scalp at an approximate angle of 45° tilted backward and laterally. Oral medication dosages of all patients will unchanged during the stimulation and follow-up periods.

Treatment:

Device: repetitive transcranial magnetic stimulation

sham group

Sham Comparator group

Description:

Patients in the sham group will administer sham stimulation using the same protocol, except that the angle of the coil is 90° (i.e., perpendicular, rather than tangential) to the skull. Oral medication dosages of all patients will unchanged during the stimulation and follow-up periods.

Treatment:

Device: repetitive transcranial magnetic stimulation