Clinical trial NCT01593982: Repetitive Transcranial Magnetic Stimulation in Symptoms of Attention Deficit Hyperactivity Disorder and Cognitive Function In Cocaine Addicts
Official title: Effect of Repetitive Transcranial Magnetic Stimulation on Symptoms of Attention Deficit Hyperactivity Disorder and Cognitive Function In Cocaine Addicts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cognition Disorders
Cocaine Dependence
ADHD
Keywords: Repetitive Transcranial Magnetic Stimulation
Cocaine Dependence
Cocaine Addicts
Attention Deficit Hyperactivity Disorder
Cognitive Function
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2012-05-08
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Even in the absence of a preliminary diagnosis of Attention Deficit Hyperactivity Disorder, symptoms of attention deficit, hyperactivity and cognitive impairment are common in cocaine addicts.

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.

Detailed description: Transcranial Magnetic Stimulation is a noninvasive technique that can influence specific areas of the brain and has very few side effects.

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.

Eligibility criteria: Inclusion Criteria:

* Cocaine Dependence Syndrome (alone or in combination with alcohol and/or nicotine dependence with symptoms of ADHD, according to the criteria of the DSM-IV-R (APA, 2000), as well as through a structured clinical interview (SCID-1/P v 2.0)
* Minimum age of 18
* Maximum age of 40
* 20 days or less abstinence.
* any psychopharmacological treatment other than clonazepam (4 mg/day)

Exclusion Criteria:

* Metallic Cerebral Implant
* 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

Primary outcomes:
measure: Wender Utah Rating Scale (WURS) - Diagnostic Criteries ADHD (DSM IV)
timeFrame: 4 weeks
Secondary outcomes:
measure: Battery of Neuropsychological Tests
timeFrame: 4 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Department and Institute of Psychiatry, General Hospital, University of Sao Paulo Medical School
Study officials:
affiliation: Laboratory of Brain Stimulation - Institute of Psychiatry, General Hospital, University of Sao Paulo Medical School
name: Debora Arnaut, PSYD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.