Classical, Spaced, or Accelerated Transcranial Magnetic Stimulation of Motor Cortex for Treating Neuropathic Pain: a 3-arm Parallel Non-inferiority Study

Status: Recruiting

Location: See location...

Intervention Type: Device

Study Type: Interventional

Study Phase: Not Applicable

SUMMARY

Neuropathic pain is frequent and drugs relieves only 50% of the patients. Repetitive transcranial magnetic stimulation (rTMS) at high frequency (HF, usually 10Hz) applied on the primary motor cortex (M1) is an effective treatment of neuropathic pain. For the treatment of chronic pain, the 'classical' HF-rTMS protocol (CHF-rTMS) include one daily session for one or two weeks as an induction phase of treatment followed by a weekly session to produce analgesic effects. However, another type of protocol is based on a more spaced repetition of HF-rTMS sessions (SHF-rTMS), including intervals of several days or weeks between two sessions, but also resulting in a significant pain relief. However, CHF-rTMS and SHF-rTMS have never been compared regarding their analgesic efficacy. Alongside with pain, depression is the other clinical condition for which HF-rTMS is proposed as an effective therapeutic strategy. Another type of rTMS paradigm, called accelerated intermittent theta burst stimulation (ACC-iTBS) protocol has been recently proposed for the treatment of depression, combining a high number of pulses delivered per session and a high number of short-duration sessions grouped into a few days of stimulation. However, this type of protocol has never been applied for the treatment of chronic pain patients. Thus, for the first time we propose to compare in a pilot study the efficacy of three different rTMS protocols for the treatment of chronic neuropathic: CHF-rTMS, SHF-rTMS, and ACC-iTBS. In this study, two protocols two rTMS protocols (CHF-rTMS and ACC-iTBS) will share the same high total number of TMS pulses (i.e. 30 000 pulses) versus an rTMS protocol (SHF-rTMS) based on a lower total number of TMS pulses (i.e. 6 400 pulses), while one protocol (CHF-rTMS) will include a higher number of days of stimulation (i.e. 10 days) compared to the two other protocols (ACC-iTBS and SHF-rTMS) (i.e. 4 days). In all cases, the motor cortical target and the intensity of stimulation will the same. Thus, this study will be able to appraise the respective influence of the number of pulses delivered (the higher the number, the greater the effect) and the number of sessions (the higher the number, the more restrictive the implementation of treatment). That is to say that the new ACC-iTBS protocol could be an optimal compromise of a more efficacious and more easy-to-perform rTMS protocol for the treatment of patients with chronic pain.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 80

Healthy Volunteers: f

View:

• (1) existence of a definite peripheral neuropathy on both clinical and neurophysiological grounds, present for at least 6 months;

• (2) neuropathic pain clearly related to the neuropathy, as defined by a score ≥ 4/10 on the questionnaire Douleur Neuropathique en 4 Questions (DN4) ;

• (3) a score ≥ 4/10 on a 0-10 numerical rating scale (NRS) concerning the average intensity of daily ongoing pain;

• (4) age between 18 and 80 years;

• (5) affiliation with the social security system;

• (6) ability to provide signed informed consent.

Locations

Other Locations

France

Henri Mondor University Hospital

RECRUITING

Créteil

Contact Information

Primary

Jean-Pascal Lefaucheur, MD, PhD

Jean-pascal.lefaucheur@aphp.fr

800-555-5555

Time Frame

Start Date: 2025-04-01

Estimated Completion Date: 2027-02-01

Participants

Target number of participants: 36

Treatments

Active_comparator: Classical HF-rTMS (CHF-rTMS)

Stimulation was applied over the hand knob area of the primary motor cortex (M1), contralateral to the pain side, corresponding to the left hemisphere. The stimulation intensity was set at 80% of the resting motor threshold.~Each session consisted of 30 trains of 100 pulses, delivered at a frequency of 10 Hz for 10 seconds per train, with an inter-train interval (ITI) of 20 seconds. This resulted in a total of 3,000 pulses per session, delivered over approximately 15 minutes.~The treatment protocol included one session per day for 5 consecutive days during the first week. Subsequently, one session per week was performed during weeks 2, 3, 4, 5, and 7.~In total, the protocol consisted of 10 sessions delivered over 7 weeks, with a cumulative number of 30,000 pulses.

Active_comparator: Spaced HF-rTMS (SHF-rTMS)

Stimulation was applied over the hand knob area of the primary motor cortex (M1), contralateral to the pain side, corresponding to the left hemisphere. The stimulation intensity was set at 80% of the resting motor threshold.~Each session consisted of 20 trains of 80 pulses, delivered at a frequency of 20 Hz for 4 seconds per train, with an inter-train interval (ITI) of 80 seconds. This resulted in a total of 1,600 pulses per session, delivered over approximately 28 minutes.~The treatment protocol included one session per week during weeks 1, 3, 5, and 7.~In total, the protocol consisted of 4 sessions delivered over 4 weeks, with a cumulative number of 6,400 pulses.

Experimental: Accelerated iTBS (ACC-iTBS)

Stimulation was applied over the hand knob area of the primary motor cortex (M1), contralateral to the pain side, corresponding to the left hemisphere. The stimulation intensity was set at 80% of the resting motor threshold.~Each session consisted of 50 trains of 30 pulses, corresponding to 10 bursts (delivered at 5 Hz over 2 seconds), with each burst containing 3 pulses at 50 Hz (lasting 60 milliseconds). The inter-train interval (ITI) was 8 seconds. This resulted in a total of 1,500 pulses per session, delivered over approximately 8 minutes.~The treatment protocol included 5 sessions per day, with an interval of 45 minutes between sessions, for 2 consecutive days during each stimulation week (from week 1 to week 7).~In total, the protocol consisted of 20 sessions delivered over 4 days, with a cumulative number of 30,000 pulses.

Related Therapeutic Areas

Chronic Pain

Neuralgia

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