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

Phase 2

• Conditions: Cognition Disorders; Cocaine Dependence; ADHD
• Interventions: Other: repetitive Transcranial Magnetic Stimulation (rTMS)

• Registration Number: NCT01593982
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Study Timeline

• Study Start: 2010-03
• Status Verified: 2012-05
• Study First Submitted: 2012-05-04
• Study First Submitted QC: 2012-05-07
• Study First Posted: 2012-05-08
• Last Update Submitted: 2012-05-22
• Last Update Posted: 2012-05-23
• Primary Completion: 2012-08
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham rTMS	repetitive Transcranial Magnetic Stimulation (rTMS)	Drug-free patients, receiving 20 sessions (1 session daily) of Sham (placebo) rTMS delivered to the left dorsolateral prefrontal cortex.
Active rTMS	repetitive Transcranial Magnetic Stimulation (rTMS)	Drug-free patients, receiving 20 sessions (1 session daily) of Active rTMS delivered to the left dorsolateral prefrontal cortex.

Primary Outcome Measures

Name	Time	Method
Wender Utah Rating Scale (WURS) - Diagnostic Criteries ADHD (DSM IV)	4 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Battery of Neuropsychological Tests	4 weeks	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).

Trial Locations

Locations (1)

Department and Institute of Psychiatry, General Hospital, University of Sao Paulo Medical School; 🇧🇷 São Paulo, Brazil