Repetitive Transcranial Magnetic Stimulation in Symptoms of Attention Deficit Hyperactivity Disorder and Cognitive Function In Cocaine Addicts

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Repetitive Transcranial Magnetic Stimulation on Symptoms of Attention Deficit Hyperactivity Disorder and Cognitive Function In Cocaine Addicts

Conditions
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Cognition Disorders, Cocaine Dependence, ADHD

Intervention / Treatment
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* Other: repetitive Transcranial Magnetic Stimulation (rTMS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sham rTMS<br>Drug-free patients, receiving 20 sessions (1 session daily) of Sham (placebo) rTMS delivered to the left dorsolateral prefrontal cortex. | Other: repetitive Transcranial Magnetic Stimulation (rTMS)<br>* 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<br>* Other names: TMS;|
| Active Comparator: Active rTMS<br>Drug-free patients, receiving 20 sessions (1 session daily) of Active rTMS delivered to the left dorsolateral prefrontal cortex. | Other: repetitive Transcranial Magnetic Stimulation (rTMS)<br>* 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<br>* Other names: TMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wender Utah Rating Scale (WURS) - Diagnostic Criteries ADHD (DSM IV) | Scales to assess attention deficit hyperactivity disorder symptoms will be applied at pre-treatment (T0) and post treatment - week 4 (T1). Reduction on the scores of WURS and synptoms of ADHD diagnostic (as on the scores of Barrat Impulsiviness Scale - BIS 11 and Minnesota Cocaine Craving Scale - MCCS; and improves Hamilton Depressive Rating Scale - HDRS 17 and Hamilton Anxiety Rating Scale - HARS 14). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Battery of Neuropsychological Tests | Cognitive performance battery will be applied at pre-treatment (T0) and post treatment - week 4 (T1). Performance of neuropsychological tests - Trail Making Test; Wisconsin Card Sorting Test; Controlled Oral Word Association Test; Victoria Stroop Test; Rey Auditory Verbal Learning Test; WAIS-III (adapted for use in Brazil) subtests Cubes, Vocabulary, Digit Span; Wechsler Logical Memory and Iowa Gambling Task (IGT). | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Repetitive Transcranial Magnetic Stimulation, Cocaine Dependence, Cocaine Addicts, Attention Deficit Hyperactivity Disorder, Cognitive Function