Repetitive Transcranial Magnetic Stimulation in Symptoms of Attention Deficit Hyperactivity Disorder and Cognitive Function In Cocaine Addicts
NCT ID: NCT01593982
Last Updated: 2012-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2010-03-31
2013-03-31
Brief Summary
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Several factors indicate that repetitive transcranial magnetic stimulation might be a strategy to aid in the treatment of symptoms of attention deficit hyperactivity disorder and cognitive function in cocaine addicts.
However, up to current days there have been no studies evaluating the effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on neurocognitive performance of individuals suffering from the ADHD.
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Detailed Description
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The treatment with transcranial magnetic stimulation requires attendance to hospital daily sessions for 4 consecutive weeks. Each session lasts up to 30 minutes.
Side effects include scalp discomfort and mild headache. No anesthesia is required.
Stimulation aims the dorsolateral prefrontal cortex, a region previously studied to treat depression symptoms with positive results.
The present technique has never been employed in previous studies, but risks are insignificant.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sham rTMS
Drug-free patients, receiving 20 sessions (1 session daily) of Sham (placebo) rTMS delivered to the left dorsolateral prefrontal cortex.
repetitive Transcranial Magnetic Stimulation (rTMS)
20 daily sessions: each with 25 trains of 10 seconds at 5Hz, with a 20 second inter-train interval, at an intensity of 120% of motor threshold.
Site: Left Dorsolateral Prefrontal Cortex
Active rTMS
Drug-free patients, receiving 20 sessions (1 session daily) of Active rTMS delivered to the left dorsolateral prefrontal cortex.
repetitive Transcranial Magnetic Stimulation (rTMS)
20 daily sessions: each with 25 trains of 10 seconds at 5Hz, with a 20 second inter-train interval, at an intensity of 120% of motor threshold.
Site: Left Dorsolateral Prefrontal Cortex
Interventions
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repetitive Transcranial Magnetic Stimulation (rTMS)
20 daily sessions: each with 25 trains of 10 seconds at 5Hz, with a 20 second inter-train interval, at an intensity of 120% of motor threshold.
Site: Left Dorsolateral Prefrontal Cortex
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Minimum age of 18
* Maximum age of 40
* 20 days or less abstinence.
* any psychopharmacological treatment other than clonazepam (4 mg/day)
Exclusion Criteria
* Pacemakers
* History of Severe Brain trauma or injury
* Organic Brain Disease
* Previous neurosurgery
* History of seizures
* Epilepsy
* Severe Somatic Disease
* History of other actual or past psychiatric diagnostics
* Clinically significant changes in laboratory test
* Any psychiatric or neurological disorder other than Cocaine Dependence with symptoms of ADHD
* Psychotic depression
* Suicidal propensities
18 Years
40 Years
MALE
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Principal Investigators
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Debora Arnaut, PSYD
Role: PRINCIPAL_INVESTIGATOR
Laboratory of Brain Stimulation - Institute of Psychiatry, General Hospital, University of Sao Paulo Medical School
Locations
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Department and Institute of Psychiatry, General Hospital, University of Sao Paulo Medical School
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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van Emmerik-van Oortmerssen K, van de Glind G, van den Brink W, Smit F, Crunelle CL, Swets M, Schoevers RA. Prevalence of attention-deficit hyperactivity disorder in substance use disorder patients: a meta-analysis and meta-regression analysis. Drug Alcohol Depend. 2012 Apr 1;122(1-2):11-9. doi: 10.1016/j.drugalcdep.2011.12.007. Epub 2011 Dec 30.
Gudjonsson GH, Sigurdsson JF, Sigfusdottir ID, Young S. An epidemiological study of ADHD symptoms among young persons and the relationship with cigarette smoking, alcohol consumption and illicit drug use. J Child Psychol Psychiatry. 2012 Mar;53(3):304-12. doi: 10.1111/j.1469-7610.2011.02489.x. Epub 2011 Nov 8.
Bloch Y, Harel EV, Aviram S, Govezensky J, Ratzoni G, Levkovitz Y. Positive effects of repetitive transcranial magnetic stimulation on attention in ADHD Subjects: a randomized controlled pilot study. World J Biol Psychiatry. 2010 Aug;11(5):755-8. doi: 10.3109/15622975.2010.484466.
Barr MS, Farzan F, Wing VC, George TP, Fitzgerald PB, Daskalakis ZJ. Repetitive transcranial magnetic stimulation and drug addiction. Int Rev Psychiatry. 2011 Oct;23(5):454-66. doi: 10.3109/09540261.2011.618827.
Other Identifiers
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0181/08
Identifier Type: -
Identifier Source: org_study_id
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