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

University of Sao Paulo General Hospital

Status and phase: Unknown; Phase 2

Conditions: Cognition Disorders; Cocaine Dependence; ADHD

Treatments: Other: repetitive Transcranial Magnetic Stimulation (rTMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01593982

0181/08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Sham rTMS

Placebo Comparator group

Description:

Drug-free patients, receiving 20 sessions (1 session daily) of Sham (placebo) rTMS delivered to the left dorsolateral prefrontal cortex.

Treatment:

Other: repetitive Transcranial Magnetic Stimulation (rTMS)

Active rTMS

Active Comparator group

Description:

Drug-free patients, receiving 20 sessions (1 session daily) of Active rTMS delivered to the left dorsolateral prefrontal cortex.

Treatment:

Other: repetitive Transcranial Magnetic Stimulation (rTMS)