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Deep rTMS in Central Neuropathic Pain Syndromes (DRTMS)

Primary Purpose

Pain, Spinal Cord Injury, Post Stroke Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
deep rTMS
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring deep repetitive transcranial magnetic stimulation, chronic pain, assessment, neuropathic pain, central pain, treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Arm Label

deep rTMS-active doble coil

deep rTMS-sham

deep rTMS-active: H-coil

Arm Description

patients undergoing of deep rTMS real with doble coil

patients undergoing to placebo deep rTMS

patients undergoing of deep rTMS real with H-coil

Outcomes

Primary Outcome Measures

Change in baseline of Pain
assessing by verbal analog scale (VAS)

Secondary Outcome Measures

Full Information

First Posted
August 27, 2013
Last Updated
May 8, 2017
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01932905
Brief Title
Deep rTMS in Central Neuropathic Pain Syndromes
Acronym
DRTMS
Official Title
Deep rTMS in Central Neuropathic Pain Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Spinal Cord Injury, Post Stroke Pain
Keywords
deep repetitive transcranial magnetic stimulation, chronic pain, assessment, neuropathic pain, central pain, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
deep rTMS-active doble coil
Arm Type
Active Comparator
Arm Description
patients undergoing of deep rTMS real with doble coil
Arm Title
deep rTMS-sham
Arm Type
Sham Comparator
Arm Description
patients undergoing to placebo deep rTMS
Arm Title
deep rTMS-active: H-coil
Arm Type
Active Comparator
Arm Description
patients undergoing of deep rTMS real with H-coil
Intervention Type
Device
Intervention Name(s)
deep rTMS
Intervention Description
Patients undergoing of repetitive transcranial magnetic stimulation for treatment of central pain
Primary Outcome Measure Information:
Title
Change in baseline of Pain
Description
assessing by verbal analog scale (VAS)
Time Frame
base line (moment of inclusion) and end of each session rTMS (4X in three months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP)
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403900
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
30952795
Citation
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.
Results Reference
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Deep rTMS in Central Neuropathic Pain Syndromes

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