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

Primary Purpose

Cognition Disorders, Cocaine Dependence, ADHD

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
repetitive Transcranial Magnetic Stimulation (rTMS)
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognition Disorders focused on measuring Repetitive Transcranial Magnetic Stimulation, Cocaine Dependence, Cocaine Addicts, Attention Deficit Hyperactivity Disorder, Cognitive Function

Eligibility Criteria

18 Years - 40 Years (Adult)MaleDoes not accept 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

Sites / Locations

  • Department and Institute of Psychiatry, General Hospital, University of Sao Paulo Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Sham rTMS

Active rTMS

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
May 4, 2012
Last Updated
May 22, 2012
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01593982
Brief Title
Repetitive Transcranial Magnetic Stimulation in Symptoms of Attention Deficit Hyperactivity Disorder and Cognitive Function In Cocaine Addicts
Acronym
rTMSinADHD
Official Title
Effect of Repetitive Transcranial Magnetic Stimulation on Symptoms of Attention Deficit Hyperactivity Disorder and Cognitive Function In Cocaine Addicts
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognition Disorders, Cocaine Dependence, ADHD
Keywords
Repetitive Transcranial Magnetic Stimulation, Cocaine Dependence, Cocaine Addicts, Attention Deficit Hyperactivity Disorder, Cognitive Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham rTMS
Arm Type
Placebo Comparator
Arm Description
Drug-free patients, receiving 20 sessions (1 session daily) of Sham (placebo) rTMS delivered to the left dorsolateral prefrontal cortex.
Arm Title
Active rTMS
Arm Type
Active Comparator
Arm Description
Drug-free patients, receiving 20 sessions (1 session daily) of Active rTMS delivered to the left dorsolateral prefrontal cortex.
Intervention Type
Other
Intervention Name(s)
repetitive Transcranial Magnetic Stimulation (rTMS)
Other Intervention Name(s)
TMS
Intervention Description
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
Primary Outcome Measure Information:
Title
Wender Utah Rating Scale (WURS) - Diagnostic Criteries ADHD (DSM IV)
Description
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).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Battery of Neuropsychological Tests
Description
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).
Time Frame
4 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Debora Arnaut, PSYD
Phone
551130698159
Email
arnautdebora@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debora Arnaut, PSYD
Organizational Affiliation
Laboratory of Brain Stimulation - Institute of Psychiatry, General Hospital, University of Sao Paulo Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department and Institute of Psychiatry, General Hospital, University of Sao Paulo Medical School
City
São Paulo
ZIP/Postal Code
SP
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debora Arnaut, PSYD
Phone
551126618159
Email
arnautdebora@hotmail.com
First Name & Middle Initial & Last Name & Degree
Philip L Ribeiro, MD
Phone
551126618159
Email
emt@hcnet.usp.br
First Name & Middle Initial & Last Name & Degree
Debora Arnaut, PSYD

12. IPD Sharing Statement

Citations:
PubMed Identifier
22209385
Citation
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.
Results Reference
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PubMed Identifier
22066497
Citation
Gudjonsson 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.
Results Reference
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PubMed Identifier
20521875
Citation
Bloch 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.
Results Reference
background
PubMed Identifier
22200135
Citation
Barr 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.
Results Reference
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Repetitive Transcranial Magnetic Stimulation in Symptoms of Attention Deficit Hyperactivity Disorder and Cognitive Function In Cocaine Addicts

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