NCT05295498

Brief Summary

Peripheral neuropathy is a frequent condition, commonly associated with pain. Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive method of modulation of brain plasticity and is regarded as one of alternative methods to alleviate pain associated with various kind of neuropathies. rTMS is usually performed once a day and the whole therapy of neuropathic pain lasts one week. In a number of recent clinical trials including patients with depression and some other disorders, rTMS was delivered several times a day, which reduced the time of the whole therapy. This approach was termed an accelerated rTMS. The purpose of this study is to investigate feasibility of accelerated rTMS in treatment of neuropathic pain.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Nov 2022Sep 2026

First Submitted

Initial submission to the registry

March 7, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

November 4, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

3.4 years

First QC Date

March 7, 2022

Last Update Submit

October 9, 2024

Conditions

Peripheral Neuropathy

Keywords

Peripheral neuropathyNeuropathic painrTMSanalgesic effect

Outcome Measures

Primary Outcomes (3)

  • Visual Analogue Scale of Pain Severity after rTMS

    An analog scale of the length of 100 millimeter. Total score of 100, with higher scores representing more severe pain. Change from baseline score in the Visual Analogue Scale to the measurement taken after finishing rTMS.

    Through study completion, an average of 1 year.

  • Visual Analogue Scale of Pain Severity First Follow-up

    An analog scale of the length of 100 millimeter. Total score of 100, with higher scores representing more severe pain. Change from baseline score in the Visual Analogue Scale to the measurement taken after two weeks after finishing rTMS.

    Before rTMS, up to one day after finishing rTMS.

  • Visual Analogue Scale of Pain Severity Second Follow-up

    An analog scale of the length of 100 millimeter. Total score of 100, with higher scores representing more severe pain. Change from baseline score in the Visual Analogue Scale to the measurement taken after four weeks after finishing rTMS.

    Before rTMS, four weeks after finishing rTMS.

Secondary Outcomes (12)

  • Numeric Pain Severity Scale after rTMS

    Before rTMS, up to one day after finishing rTMS.

  • Numeric Pain Severity Scale First Follow-up

    Before rTMS, two weeks after finishing rTMS.

  • Numeric Pain Severity Scale Second Follow-up

    Before rTMS, four weeks after finishing rTMS.

  • Neuropathic Pain Symptoms Inventory after rTMS

    Before rTMS, up to one day after finishing rTMS.

  • Neuropathic Pain Symptoms Inventory First Follow-up

    Before rTMS, two weeks after finishing rTMS.

  • +7 more secondary outcomes

Study Arms (2)

Active repetitive transcranial magnetic stimulation

EXPERIMENTAL

10 hertz (Hz) rTMS will be administered over the primary motor area. Therapy will include 6 sessions (three sessions in two consecutive days). In every sessions 1500 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.

Device: Active repetitive transcranial magnetic stimulation

Sham repetitive transcranial magnetic stimulation

SHAM COMPARATOR

Sham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.

Device: Sham repetitive transcranial magnetic stimulation

Interventions

Active repetitive transcranial magnetic stimulationDEVICE

High frequency rTMS over the primary motor area to induce the long term potentiation of primary motor areas for the muscles of upper extremity.

Active repetitive transcranial magnetic stimulation
Sham repetitive transcranial magnetic stimulationDEVICE

Sham stimulation to mimic the high frequency rTMS over the primary motor area.

Sham repetitive transcranial magnetic stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of peripheral neuropathy
  • Neuropathic pain of constant severity since not less than a month and requiring use of analgesics more than once a week

You may not qualify if:

  • Severe depression
  • Personality disorders and other psychiatric conditions, which could disturb the participation in the study
  • Cognitive deficits, which could disturb the participation in the study
  • Epilepsy
  • Presence of magnetic material in the reach of magnetic field
  • Pregnancy
  • Likelihood to get pregnant
  • Intracranial electrodes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jagiellonian University Medical College

Krakow, 31008, Poland

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System DiseasesNeuralgia

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tomasz Klupa, Professor

    Jagiellonian University

    STUDY CHAIR

Central Study Contacts

Jakub M Antczak, MD

CONTACT

+48 795 421 153jakub.antczak@uj.edu.pl

Gabriela G Rusin, MD

CONTACT

+48 601 661 607gabriela.rusin@doctoral.uj.edu.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Triple (Participant, Investigator, Outcomes Assessor). Sham stimulation will be provided by holding the stimulating coil perpendicularly to the scalp, which assures similar impression as during active stimulation but prevents significant magnetic field to reach the brain tissue.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment. Patients will be randomly assigned to active or to sham stimulation.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 25, 2022

Study Start

November 4, 2022

Primary Completion

March 31, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

October 10, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

After completing the study, the age and gender of participants as well as the scores and results of all outcome measurements made at baseline, after rTMS, at the first and at the second follow-up will be made available to other researchers on request.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The data will become available after the study results will be published.
Access Criteria
On request sent by e-mail to jakub.antczak@uj.edu.pl

Locations

PL(1)