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

May 22, 2012 updated by: University of Sao Paulo General Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • São Paulo, Brazil, SP
        • Recruiting
        • Department and Institute of Psychiatry, General Hospital, University of Sao Paulo medical school
        • Contact:
        • Contact:
        • Principal Investigator:
          • Debora Arnaut, PSYD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Sham rTMS
Drug-free patients, receiving 20 sessions (1 session daily) of Sham (placebo) rTMS delivered to the left dorsolateral prefrontal cortex.
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 Names:
  • TMS
Active Comparator: Active rTMS
Drug-free patients, receiving 20 sessions (1 session daily) of Active rTMS delivered to the left dorsolateral prefrontal cortex.
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 Names:
  • TMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wender Utah Rating Scale (WURS) - Diagnostic Criteries ADHD (DSM IV)
Time Frame: 4 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Battery of Neuropsychological Tests
Time Frame: 4 weeks

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).
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Debora Arnaut, PSYD, Laboratory of Brain Stimulation - Institute of Psychiatry, General Hospital, University of Sao Paulo Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

August 1, 2012

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

May 4, 2012

First Submitted That Met QC Criteria

May 7, 2012

First Posted (Estimate)

May 8, 2012

Study Record Updates

Last Update Posted (Estimate)

May 23, 2012

Last Update Submitted That Met QC Criteria

May 22, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0181/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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