Deep rTMS in Central Neuropathic Pain Syndromes (DRTMS)

Pain affects up to 30% of the general population. In particular, neuropathic pain (NeP) is caused by lesion or desease affecting peripheral or central somatosensory pathways and affects 7% of the adult population. Despite the availability of evidence based pharmacological and surgical treatment for NeP, about 50% of patients remais symptomatic despite best medical treatment. Some neuropathic pain syndromes are specially refractory. In particular, central NeP is caused by disease or lesion to central structures involves in somatosensory integration of nociceptive information is non-responsive to drugs usually employed in other NeP syndromes. Classical neuromodulatory techniques such as conventional repetitive Transcranial Magnetic Stimulation aiming at the motor of prefrontal cortices are ineffective to relieve pain in this population. Recently new technology advances have made possible non-invasive stimulation of deeper cortical targets. Some of them are activelly involved in the integration of the perception of pain, such as the anterior cingulate cortex or the posterior insula. The aim this study is to treat 90 patients with central pain (post stroke pain, spinal cord lesions after trauma or demyelinizating diseases) under best medical pharmacological treatment in three different conditions: AAC (n= 30 with the H-Coil), Superior Posterior Insula (SPI) n=30 cooled double cone coil double cool coil, and sham(n=30). Each patients will undergo daily stimulation for a week, then weekly stimulations for 3 months (total of 17 sessions). The main study outcome is pain relief at the last stimulation week (visual-analogic scale). Secondary end-points are changes in the McGill Pain Questionnaire, Neuropathic Pain Symptom Inventory, DN4 questionnaire, SF -36, brief pain inventory and cognitive assessment including the trail making test A and B, Strrop color interference test, and subscalles from the CERAD. All patients will undergo quantitative sensory test and measurements of cortical excitability over M1 before and after to treatment.

Study Overview

• Status: Completed
• Conditions: Pain; Spinal Cord Injury; Post Stroke Pain
• Intervention / Treatment: Device: deep rTMS

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05403900
      • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signed term of informed consent
• central pain

Exclusion Criteria:

• Trauma of Skull, epilepsy don't treated,
• Use of medications decrease the seizure threshold
• Patients in use of drugs, how cocaine and alcohol
• neurosurgical clips, pacemakers, increased intracranial pressure (risk of sequelae after seizure)
• Pregnant or lacting women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: deep rTMS-active doble coil; patients undergoing of deep rTMS real with doble coil	Device: deep rTMS; Patients undergoing of repetitive transcranial magnetic stimulation for treatment of central pain
Sham Comparator: deep rTMS-sham; patients undergoing to placebo deep rTMS	Device: deep rTMS; Patients undergoing of repetitive transcranial magnetic stimulation for treatment of central pain
Active Comparator: deep rTMS-active: H-coil; patients undergoing of deep rTMS real with H-coil	Device: deep rTMS; Patients undergoing of repetitive transcranial magnetic stimulation for treatment of central pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in baseline of Pain	assessing by verbal analog scale (VAS)	base line (moment of inclusion) and end of each session rTMS (4X in three months)

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Publications and helpful links

General Publications

• Galhardoni R, Aparecida da Silva V, Garcia-Larrea L, Dale C, Baptista AF, Barbosa LM, Menezes LMB, de Siqueira SRDT, Valerio F, Rosi J Jr, de Lima Rodrigues AL, Reis Mendes Fernandes DT, Lorencini Selingardi PM, Marcolin MA, Duran FLS, Ono CR, Lucato LT, Fernandes AMBL, da Silva FEF, Yeng LT, Brunoni AR, Buchpiguel CA, Teixeira MJ, Ciampi de Andrade D. Insular and anterior cingulate cortex deep stimulation for central neuropathic pain: Disassembling the percept of pain. Neurology. 2019 Apr 30;92(18):e2165-e2175. doi: 10.1212/WNL.0000000000007396. Epub 2019 Apr 5.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: August 27, 2013
• First Submitted That Met QC Criteria: August 29, 2013
• First Posted (Estimate): August 30, 2013

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: chronic pain; treatment; neuropathic pain; assessment; central pain; deep repetitive transcranial magnetic stimulation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Neuralgia; Spinal Cord Injuries
• Other Study ID Numbers: RGDCA-02