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OpenTrials
Completed

NCT Number: NCT01746355

Assessment and Treatment Patients With Atypical Facial Pain Trough Repetitive Transcranial Magnetic Stimulation

Atypical Facial Pain is a chronic condition and presents controversies during diagnostic and treatment, between specialist not have consensus about the pathophysiology. It is possible consider this entitie a potential neuropathic cause without pathological signs. It knows the repetitive transcranial magnetic presents good results in the treatment of chronic pain coditions. The aim this study is evaluated the thresholds and excitability cortical in patients with AFP and verify the patterns of improvement in pain for patients undergoing rTMS compared to controls, as well as the therapeutic response to neuromodulation procedures. This enroll 20 patients with DAF and 20 controls treated with rTMS (5 sessions) and evaluated through questionnaires (EDOF clinical record, McGill Pain Questionnaire, Visual Analogue Scale, Inventory of symptoms of neuropathic pain, neuropathic pain DN4 questionnaire, SF -36, brief pain inventory). At the end of the data will be statistically analyzed and expressed as mean and standard deviation, and analyzed by Student's t test, analysis of variance (ANOVA), Tukey-Kramer and Pearson correlation. The level of significance is 5%. The results will be published in journals indexed in the area both nationally and internationally and presented at conferences and scientific meetings.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

São Paulo, 05403900, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fulfill criteria of Atypical Facial Pain by International Headache Society
  • Signed Term of Informed Consent

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

Treatment and study plan

rTMS

Procedure

Patients undergoing of repetitive transcranial magnetic stimulation for treatment of AFP.

Primary outcomes

  1. Change in Baselin of Pain

    Time frame: base line (moment of inclusion) and end of each session rTMS (4X in three months)

    Assessing by verbal analog scale (VAS)

Secondary outcomes

  1. Excitability cortical

    Time frame: baseline (in the moment of inclusion) and end of each session of rTMS (4X in three months)

    Changes in the measure of excitability cortical

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Acronym: EMTr-AFP

Important dates

Study start
2011
Primary completion
2012
Study completion
2014
First posted
Dec 10, 2012
Registry last updated
Apr 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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