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Deep rTMS in Central Neuropathic Pain Syndromes

Deep rTMS in Central Neuropathic Pain Syndromes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01932905
Acronym
DRTMS
Enrollment
120
Registered
2013-08-30
Start date
2011-03-31
Completion date
2015-08-31
Last updated
2017-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Post Stroke Pain, Spinal Cord Injury

Keywords

deep repetitive transcranial magnetic stimulation, chronic pain, assessment, neuropathic pain, central pain, treatment

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.

Interventions

DEVICEdeep rTMS

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

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in baseline of Painbase line (moment of inclusion) and end of each session rTMS (4X in three months)assessing by verbal analog scale (VAS)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026