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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of Sao Paulo General Hospital.
Recruitment status was  Recruiting
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
  Purpose

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.


Condition Intervention Phase
Cognition Disorders
Cocaine Dependence
ADHD
Other: repetitive Transcranial Magnetic Stimulation (rTMS)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Repetitive Transcranial Magnetic Stimulation on Symptoms of Attention Deficit Hyperactivity Disorder and Cognitive Function In Cocaine Addicts

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • 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).



Secondary Outcome Measures:
  • 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).



Estimated Enrollment: 40
Study Start Date: March 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: TMS

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593982

Contacts
Contact: Debora Arnaut, PSYD 551130698159 arnautdebora@hotmail.com

Locations
Brazil
Department and Institute of Psychiatry, General Hospital, University of Sao Paulo Medical School Recruiting
São Paulo, Brazil, SP
Contact: Debora Arnaut, PSYD    551126618159    arnautdebora@hotmail.com   
Contact: Philip L Ribeiro, MD    551126618159    emt@hcnet.usp.br   
Principal Investigator: Debora Arnaut, PSYD         
Sponsors and Collaborators
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
  More Information

Additional Information:
Publications:
Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01593982     History of Changes
Other Study ID Numbers: 0181/08
Study First Received: May 4, 2012
Last Updated: May 22, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo General Hospital:
Repetitive Transcranial Magnetic Stimulation
Cocaine Dependence
Cocaine Addicts
Attention Deficit Hyperactivity Disorder
Cognitive Function

Additional relevant MeSH terms:
Cognition Disorders
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Cocaine-Related Disorders
Substance-Related Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Chemically-Induced Disorders
Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014