Investigation of the efficacy of transcranial static magnetic field stimulation for postherpetic neuralgia

JRCT ID: jRCTs062240001

Registered date:09/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: postherpetic neuralgia
• Date of first enrollment: 09/04/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): The patient is seated in a reclining chair, and a stimulator with three neodymium magnets or a pseudo-stimulator with three stainless steel cylinders which are the same shape and mass as the magnets is fixed with an arm over the primary motor cortex contralateral to the painful side. Then patient is asked to rest for 20 minutes. The above stimulation is performed once a day for 5 consecutive days.

Outcome(s)

Primary Outcome

Numerical Rating Scale (NRS) at each of the following time points
The NRS immediately before stimulation on day 1 is used as the baseline.
Immediately after stimulation on days 1 and 5, and on day 12

Secondary Outcome

Magnitude of paired-pulse suppression in the inter-vertex amplitude of N20-P25 among the components of the somatosensory evoked potentials produced by stimulation of the median nerve on the painful side at 30 ms and 100 ms intervals at each of the following time points
Immediately before and after stimulation on days 1 and 5

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. patients who are at least 18 years of age at the time of consent (regardless of gender)
2. patients with persistent postherpetic neuralgia for at least 3 months despite medications
3. patients with a Numerical Rating Scale of 4 or higher at the time of consent
4. patients who can provide written consent for participation in this study

Exclude criteria

1. patients with metal in their body (cardiac pacemakers, cochlear implants, etc.)
2. patients with a history of epilepsy
3. patients with a history of severe head injury or intracranial surgery
4. patients with brain tumors
5. women who are pregnant or may be pregnant
6. patients with more severe pain than postherpetic neuralgia
7. patients with bilateral postherpetic neuralgia
8. patients who have had a change in the content or dosage of pain medications or who have received a nerve block within 4 weeks
9. patients with serious psychiatric disorders
10. patients with a history of alcohol or drug abuse
11. patients who are participating or intend to participate in other clinical research studies while participating in this study
12. patients who are determined by the principal investigator or subinvestigator to be unjustly disadvantaged by participation in the research
13. patients whose participation in the study has been determined by the principal investigator or a subinvestigator to cause obvious difficulties in the conduct or evaluation of this clinical study
14. the principal investigator or a research associate investigator of this study, a family member of the principal investigator or a research associate investigator of this study, or an employee of the medical institution where this study is being conducted

Related Information

• Primary Sponsor: Narasaki Soshi