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

NCT ID: NCT01593982

Last Updated: 2012-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-03-31

Brief Summary

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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

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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.

Conditions

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Cognition Disorders Cocaine Dependence ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sham rTMS

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

Group Type PLACEBO_COMPARATOR

repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type OTHER

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

Active rTMS

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

Group Type ACTIVE_COMPARATOR

repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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TMS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Debora Arnaut, PSYD

Role: PRINCIPAL_INVESTIGATOR

Laboratory of Brain Stimulation - Institute of Psychiatry, General Hospital, University of Sao Paulo Medical School

Locations

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

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Debora Arnaut, PSYD

Role: CONTACT

551130698159

Facility Contacts

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Debora Arnaut, PSYD

Role: primary

551126618159

Philip L Ribeiro, MD

Role: backup

551126618159

References

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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.

Reference Type BACKGROUND
PMID: 22209385 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22066497 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20521875 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22200135 (View on PubMed)

Other Identifiers

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0181/08

Identifier Type: -

Identifier Source: org_study_id

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