Repetitive Transcranial Magnetic Stimulation in Central Neuropathic Pain

NCT02386969 | Completed

• 2 other identifiers: 14082072015-A00065-44
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain.

Conditions

Neuropathic Pain

Keywords

Neuropathic Pain; repetitive transcranial magnetic stimulation (rTMS)

Outcome Measures

Primary Outcomes (2)

• Percentage of pain relief (0%= " no pain relief " and 100% " complete pain relief ")

  Percentage of pain relief compared to the beginning of the period of the study before the first stimulation

  3 weeks later the last session of rTMS (active ) so week n°12

• Percentage of pain relief (0%= " no pain relief " and 100% " complete pain

  Percentage of pain relief compared to the beginning of the period of the study before the first stimulation

  3 weeks later the last session of rTMS (sham) so week n°29.

Secondary Outcomes (6)

• Intensity of " average pain " assess by a visual analogue scale (VAS) of 100 mm (0= " no pain " and 100= " worst pain imaginable ").

  3 weeks after the last sessions of rTMS (real or sham), so week n°12 and n°29.

• Intensity of " average pain " with VAS before each session compared to the previous meeting (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)

  before each session (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)

• Percentage relief of pain before each session compared to the previous meeting (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)

  before each session (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)

• Neuropathic dimension

  at each session (or weeks number: 0, 3, 6, 9, 12 and 17, 20, 23, 26, 29)

• - Percentage of responders to the treatment real rTMS: subjects whom the Percentage of pain relief at the end of each period of 4 sessions (weeks n°12 and 29) is at least 15%.

  at the end of each period of 4 sessions (weeks n°12 and 29)

Study Arms (2)

Active rTMS then sham rTMS

EXPERIMENTAL

Active rTMS in 1st period and sham rTMS in 2nd period

Device: active rTMS then sham rTMS

Sham rTMS then active rTMS

EXPERIMENTAL

Sham rTMS in 1st period and active rTMS in 2nd period

Device: sham rTMS then active rTMS

Interventions

active rTMS then sham rTMS DEVICE

A first period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months

Active rTMS then sham rTMS

sham rTMS then active rTMS DEVICE

A first period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months

Sham rTMS then active rTMS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Central neuropathic pain
• Chronic pain with an average pain intensity is greater than or equal to 40/100
• Pain presents a daily or almost daily (at least 4 days out of 7)
• Pain presents for more than 6 months
• Patients who signed informed consent,
• Patients can be monitored for the duration of the study (29 weeks)
• Patients affiliated to a health insurance plan or entitled,
• Patients with a cerebral MRI T1.

You may not qualify if:

• Labor dispute or Accident,
• Contraindication to rTMS (treatment with electroconvulsive therapy during the previous month, epilepsy and / or a history of epilepsy, history of head trauma, neurosurgical injury; intracranial hypertension metal clip; pacemaker pregnant or lactating women)
• Abuse of drugs or psychoactive substances
• Peripheral Neuropathic Pain,
• Neuropathic pain within the framework of a progressive disease (HIV, cancer, non-stabilized system disease)
• Intermittent pain,
• Pain in less than 6 months,
• Patients unable to understand informed consent, under guardianship,
• Patients refusing to stop or can not stop the prohibited treatment during the study,

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roland PEYRON, MD PhD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 12, 2015
• Study Start: November 11, 2015
• Primary Completion: March 29, 2018
• Study Completion: September 12, 2018
• Last Updated: April 26, 2021

Record last verified: 2021-04

Locations

FR (1)