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

This study is currently recruiting participants.
Verified May 2012 by University of Sao Paulo General Hospital
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01593982
First received: May 4, 2012
Last updated: May 22, 2012
Last verified: May 2012
History of Changes

May 4, 2012
May 22, 2012
March 2010
August 2012   (final data collection date for primary outcome measure)
Wender Utah Rating Scale (WURS) - Diagnostic Criteries ADHD (DSM IV) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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).
Same as current
Complete list of historical versions of study NCT01593982 on ClinicalTrials.gov Archive Site
Battery of Neuropsychological Tests [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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).
Same as current
Not Provided
Not Provided
 
Repetitive Transcranial Magnetic Stimulation in Symptoms of Attention Deficit Hyperactivity Disorder and Cognitive Function In Cocaine Addicts
Effect of Repetitive Transcranial Magnetic Stimulation on Symptoms of Attention Deficit Hyperactivity Disorder and Cognitive Function In Cocaine Addicts

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Cognition Disorders
  • Cocaine Dependence
  • ADHD
Other: 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 Name: TMS
  • Placebo Comparator: Sham rTMS
    Drug-free patients, receiving 20 sessions (1 session daily) of Sham (placebo) rTMS delivered to the left dorsolateral prefrontal cortex.
    Intervention: Other: repetitive Transcranial Magnetic Stimulation (rTMS)
  • Active Comparator: Active rTMS
    Drug-free patients, receiving 20 sessions (1 session daily) of Active rTMS delivered to the left dorsolateral prefrontal cortex.
    Intervention: Other: repetitive Transcranial Magnetic Stimulation (rTMS)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
March 2013
August 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 40 Years
No
Contact: Debora Arnaut, PSYD 551130698159 arnautdebora@hotmail.com
Brazil
 
NCT01593982
0181/08
No
University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
Not Provided
Principal Investigator: Debora Arnaut, PSYD Laboratory of Brain Stimulation - Institute of Psychiatry, General Hospital, University of Sao Paulo Medical School
University of Sao Paulo General Hospital
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP