Comparison of rTMS and H Coil in Neuropathic Pain

NCT03370107 | Completed

• 1 other identifier: HNEP4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

rTMS of the motor cortex is an increasingly established analgesic technique for the treatment of neuropathic pain. However its efficacy is generally modest. One reason may be the that conventional rTMS targets only superficial and small cortical regions of the human brain. A newer cooled coil, the Hesed (H) coils, now allows deep and larger surface of stimulation and has been suggested to have analgesic effects in a small pilot trial in diabetic painful polyneuropathy. Based on its deeper mechanism of action and larger surface of stimulation, we hypothesize that this technique will be more effective than rTMS in patients with central pain, a highly unmet medical need. The primary objective of the present study will be to compare the efficacy of H coil, conventional rTMS and sham stimulation of the primary motor cortex in patients central neuropathic pain. Major secondary objectives will be to directly compare the analgesic efficacy of H coil versus conventional rTMS, and compare the efficacy of both techniques in patients with lower limb pain and those with upper limb pain/face. This will be a randomized tricentric sham controlled study

Conditions

Central Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in the self reported average pain intensity (NRS from 0 to 10) over the past 24 hours from baseline to week 3 after the end of the last stimulation

  Comparison between the efficacy of sham, rTMS and H coil on average pain intensity over the course of the treatment

  the average of pain scores (NRS for pain intensity) will be conducted before each treatment for up to 3 weeks after each treatment session (treatment effect)

Secondary Outcomes (12)

• Score of each neuropathic dimension (ie symptom combinations) on the Neuropathic pain symptom inventory (NPSI) (Bouhassira et al 2004) .

  1 week and 3 weeks after the end of each stimulation period

• proportion of responders

  1 week and 3 weeks after the end of each stimulation period

• intensity of average pain

  1 week and 3 weeks after the end of each stimulation period

• Pain interference

  1 week and 3 weeks after the end of each stimulation period

• Hospital Anxiety and Depression Scale (HAD)

  1 week and 3 weeks after the end of each stimulation period

Study Arms (2)

Active rTMS and H coil

ACTIVE COMPARATOR

Device: rTMS

sham rTMS and Hcoil

PLACEBO COMPARATOR

Device: rTMS

Interventions

rTMS DEVICE

Conventional magnetic stimulations will be applied with a MacPROX100 machine using neuronavigation system. H-coil rTMS will be delivered with the Brainsway H-coil (Brainsway, Jerusalem, Israel) applied via a helmet placed on the head corresponding to the primary motor cortex (H10 coil) and connected to a Masgtim Rapid2 stimulatior (Mastim, Whitland, UK), while sham stimulation will be delivered with a sham coil placed in the helmet encasing the active rTMS coil. Active rTMS sessions with H-coil will use exactly the same parameters of stimulation as conventional rTMS.

Active rTMS and H coil; sham rTMS and Hcoil

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years and less than 80 years
• Average pain intensity ≥ 4/10 at screening and randomization
• Persistent pain for at least 6 months
• Stable pharmacological treatment for pain
• Central neuropathic pain as diagnosed by DN4 and NeuPSIG classification algorithm related to stable multiple sclerosis, spinal cord lesion or past stroke

You may not qualify if:

• Any clinically significant or unstable medical or psychiatric disorder
• History of substance abuse
• Litigation
• Pregnancy/lactation
• Contraindication to rTMS or Hcoil
• Intermittent pain, more severe pain than neuropathic pain and diffuse pain

Sponsors & Collaborators

• Hospital Ambroise Paré Paris: lead

Study Sites (1)

Department of Pain Management and Research, Oslo University Hospital and Faculty of Medicine, University of Oslo, Norway

Oslo, 0424, Norway

Location

Study Officials

• Nadine ATTAL

  Coordinator of the study

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The sham coil of the Hcoil procedure produces a similar acoustic artefact and scalp sensation as the active coil and mimics the facial muscle activation induced by the active coil. The sham stimulation of the conventional rTMS will be carried out with the opposite face of the coil (biface coil) of identical size, color and shape emitting a sound similar to that emitted by the active coil (B65 A/P Butterfly Coil Magventure).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator and coordinator

Model Details: Patients will be randomly assigned to one of 2 treatment groups: active rTMS and Hcoil or sham rTMS and sham Hcoil, according to a 2 : 1 ratio (2 for active, 1 for placebo).

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 12, 2017
• Study Start: January 3, 2018
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: October 17, 2022

Record last verified: 2022-10

Locations

NO (1)