Single Comparative Study of Magnetic Stimulation for Neuropathic Pain

JRCT ID: jRCTs072200021

Registered date:15/07/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Neuropathic pain patients including Minamata disease
• Date of first enrollment: 27/04/2021
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Using High Frequency Transcranial Magnetic Stimulator (MagPro X100, Mag Venture), magnetic stimulation therapy is performed a total of 5 times for 5 consecutive days.

Outcome(s)

Primary Outcome

Amount of change of the mean VAS score for one week after the end of treatment from baseline VAS score*.
*Baseline VAS score : Mean VAS score performed for 1 week before treatment.

Secondary Outcome

Amount of change of the mean VAS score for each week of 2nd, 3rd, and 4th week after the treatment from baseline VAS score.
Amount of change of the pain threshold in transcranial magnetic stimulation treatment at each time point (immediately after 5th day-treatment, 28 days after treatment).
Amount of change of the pain evaluation scale (SF-MPQ-2) at each time point (immediately after 5th day-treatment, 28 days after treatment).
Amount of change of Beck Depression Inventory (BDI) at each time point of (immediately after 5th day-treatment, 28 days after treatment).
Satisfaction with treatment (PGIC) at immediately after 5th day-treatment and 28 days after treatment.
Amount of change of VAS score from the pre-treatment value in the days during the treatment period (1st - 5th day).

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Age at the time of consent acquisition: 50 years old or older / Gender: No matter / ADL: Relatively maintained / Not excluded by TMS registration form / Neuropathic pain had been continuing for 6 months or more at the time of consent obtained / The average value of VAS for one week during the screening period is 4.0 or more / The VAS could be recorded for one week during the screening period
• Exclude criteria: Those who cannot obtain written consent for this study / Those who meet the eligibility criteria but their attending physicians have determined that it is impossible for them to enrolled in the clinical study / Those with diabetic neuropathy / Those for whome 3T MRI examination cannot be performed / Those with cognitive decline (MMSE<24) / Pregnant or potentially pregnant

Related Information

• Primary Sponsor: Nakamura Masaaki