Deep rTMS in Central Neuropathic Pain Syndromes (DRTMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Daniel Ciampi Araujo de Andrade, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01932905
First received: August 27, 2013
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Pain
Spinal Cord Injury
Post Stroke Pain
Device: deep rTMS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Deep rTMS in Central Neuropathic Pain Syndromes

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Change in baseline of Pain [ Time Frame: base line (moment of inclusion) and end of each session rTMS (4X in three months) ] [ Designated as safety issue: No ]
    assessing by verbal analog scale (VAS)


Estimated Enrollment: 90
Study Start Date: March 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01932905

Contacts
Contact: Daniel Ciampi, MD, PhD + 55 11 99775-3538 ciampi@usp.br
Contact: Ricardo Galhardoni, PhD student 55 11 984927484 rgalhardoni@gmail.com

Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP) Recruiting
São Paulo, SP, Brazil, 05403900
Sponsors and Collaborators
University of Sao Paulo
  More Information

No publications provided

Responsible Party: Daniel Ciampi Araujo de Andrade, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01932905     History of Changes
Other Study ID Numbers: RGDCA-02
Study First Received: August 27, 2013
Last Updated: August 29, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
deep repetitive transcranial magnetic stimulation
chronic pain
assessment
neuropathic pain
central pain
treatment

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Spinal Cord Diseases
Neuralgia
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 29, 2014