Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05295498

Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Pain Related to Peripheral Neuropathy

Led by Jakub Antczak · Updated on 2024-10-10

70

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Peripheral neuropathy is a common condition often accompanied by pain that can be difficult to treat with medication. Researchers are evaluating accelerated repetitive Transcranial Magnetic Stimulation (rTMS), a noninvasive brain stimulation method, to see if it can reduce neuropathic pain more quickly. This study aims to test the feasibility of delivering rTMS multiple times a day instead of once daily, which may shorten the overall treatment time. The study compares two groups: one receiving active high-frequency rTMS over the primary motor area and another receiving sham stimulation designed to mimic the active treatment without significant brain stimulation. The active treatment involves six sessions over two consecutive days, with each session delivering 1500 magnetic pulses at 90% of the resting motor threshold. Sham treatment uses a coil held perpendicularly to the scalp to create a similar sensation without actual magnetic stimulation. Participants will undergo pain assessments using the Visual Analogue Scale before treatment, shortly after, and during follow-ups up to one year. Additional measures include numeric pain scales, neuropathic pain symptom inventories, insomnia scales, and muscle strength tests at various time points up to four weeks after treatment. The study uses randomized assignment and triple blinding to compare treatment effects safely and accurately. Participant involvement includes therapy sessions and multiple evaluations to monitor pain, symptoms, and safety throughout the study period.

CONDITIONS

Brief Title

Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Neuropathic Pain

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of peripheral neuropathy
  • Neuropathic pain lasting at least one month and requiring analgesics more than once a week
  • Pain intensity score of 30 millimeters or higher on a 100 millimeter visual analog scale at inclusion
Not Eligible

You will not qualify if you...

  • Severe depression
  • Personality disorders or other psychiatric conditions interfering with study participation
  • Cognitive deficits interfering with study participation
  • Epilepsy
  • Presence of magnetic material within reach of the magnetic field
  • Pregnancy or likelihood of becoming pregnant
  • Presence of intracranial electrodes

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 consecutive days

Participants receive accelerated repetitive transcranial magnetic stimulation (rTMS) over the primary motor area for neuropathic pain. The therapy includes 6 sessions of stimulation across two consecutive days.

3 sessions per day for 2 days (in-person)

Follow-up

Duration - Up to 4 weeks after treatment

Participants are monitored after treatment to assess pain severity and other symptoms up to 4 weeks following the therapy.

3 visits (up to 1 day, 2 weeks, and 4 weeks post-treatment, in-person)

Trial Site Locations

Total: 1 location

1

Jagiellonian University Medical College

Krakow, Poland, 31008

Actively Recruiting

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Research Team

J

Jakub M Antczak, MD

G

Gabriela G Rusin, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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