Repetitive Transcranial Magnetic Stimulation in Symptoms of Attention Deficit Hyperactivity Disorder and Cognitive Function In Cocaine Addicts
rTMSinADHD
Effect of Repetitive Transcranial Magnetic Stimulation on Symptoms of Attention Deficit Hyperactivity Disorder and Cognitive Function In Cocaine Addicts
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 4, 2012
CompletedFirst Posted
Study publicly available on registry
May 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMay 23, 2012
May 1, 2012
2.4 years
May 4, 2012
May 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Battery of Neuropsychological Tests
4 weeks
Study Arms (2)
Sham rTMS
PLACEBO COMPARATORDrug-free patients, receiving 20 sessions (1 session daily) of Sham (placebo) rTMS delivered to the left dorsolateral prefrontal cortex.
Active rTMS
ACTIVE COMPARATORDrug-free patients, receiving 20 sessions (1 session daily) of Active rTMS delivered to the left dorsolateral prefrontal cortex.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
- days or less abstinence.
- any psychopharmacological treatment other than clonazepam (4 mg/day)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department and Institute of Psychiatry, General Hospital, University of Sao Paulo Medical School
São Paulo, São Paulo, SP, Brazil
Related Publications (4)
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.
PMID: 22209385BACKGROUNDGudjonsson 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.
PMID: 22066497BACKGROUNDBloch 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.
PMID: 20521875BACKGROUNDBarr 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.
PMID: 22200135BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Debora Arnaut, PSYD
Laboratory of Brain Stimulation - Institute of Psychiatry, General Hospital, University of Sao Paulo Medical School
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2012
First Posted
May 8, 2012
Study Start
March 1, 2010
Primary Completion
August 1, 2012
Study Completion
March 1, 2013
Last Updated
May 23, 2012
Record last verified: 2012-05