Deep rTMS in Central Neuropathic Pain Syndromes

NCT ID: NCT01932905

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2015-08-31

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.

Conditions

Pain; Spinal Cord Injury; Post Stroke Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

deep rTMS-active doble coil

patients undergoing of deep rTMS real with doble coil

Group Type: ACTIVE_COMPARATOR

deep rTMS

Intervention Type: DEVICE

Patients undergoing of repetitive transcranial magnetic stimulation for treatment of central pain

deep rTMS-sham

patients undergoing to placebo deep rTMS

Group Type: SHAM_COMPARATOR

deep rTMS

Intervention Type: DEVICE

Patients undergoing of repetitive transcranial magnetic stimulation for treatment of central pain

deep rTMS-active: H-coil

patients undergoing of deep rTMS real with H-coil

Group Type: ACTIVE_COMPARATOR

deep rTMS

Intervention Type: DEVICE

Patients undergoing of repetitive transcranial magnetic stimulation for treatment of central pain

Interventions

deep rTMS

Patients undergoing of repetitive transcranial magnetic stimulation for treatment of central pain

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Daniel Ciampi Araujo de Andrade

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 30952795 (View on PubMed)

Other Identifiers

RGDCA-02

Identifier Type: -

Identifier Source: org_study_id