Methylphenidate on Intracortical Inhibition in Methamphetamine Abusers Attention Deficit Hyperactivity Disorder (ADHD)

NCT01651169 | Unknown DMC

• 1 other identifier: 90-04-49-16359
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Previous studies using transcranial magnetic stimulation (TMS) with paired pulse protocols have shown that a conditioning TMS pulse applied to the human motor cortex changes the excitability of motor pathways from the motor cortex to spinal motorneurons. These effects depended on the stimulus intensity of both conditioning and test pulse and also the ISI). A characteristical sequence of inhibition (short interval cortical inhibition \[SICI\], GABA-Aerg), facilitation (intracortical facilitation \[ICF\]), and inhibition again (long interval cortical inhibition \[LICI\], GABA-Berg) is thought to be physiologically involved in motor control. Previous studies have also shown that neuronal inhibitory motor circuits are also disturbed in ADHD which will be restored by using methylphenidate. In this study the investigators sought to investigate if methamphetamine abuse (from the same chemical class of medications) will alter such effects of methylphenidate.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Paired Transcranial Magnetic Stimulation; Methamphetamine abuse, ADHD, Methylphenidate; We study the effect of Methamphetamine abuse on Intracortical Inhibition, in ADHD patients, treated with Methylphenidate.

Outcome Measures

Primary Outcomes (1)

• Conners ADHD Rating Scale

  The primary outcome measure for the study is Conners which measure clinical improvement on ADHD symptoms

  1 week

Secondary Outcomes (1)

• Change of Motor Evoked Potential (MEP)

  1 week

Study Arms (2)

methylphenidate tablets (10mg), ADHD

EXPERIMENTAL

Fifteen patients of ADHD

Other: methylphenidate tablets and Inter-stimulus Intervals (ISI)

methylphenidate tablets, Methamphetamine abusers and ADHD

EXPERIMENTAL

Fifteen patients of ADHD with Methamphetamine abuse for at least 2 years plus

Other: methylphenidate tablets and Inter-stimulus Intervals (ISI)

Interventions

methylphenidate tablets and Inter-stimulus Intervals (ISI) OTHER

We administer 2 single doses of methylphenidate tablets (10mg) separated by a week interval. A paired pulse protocols will be performed with ten single (unconditioned test pulse) and ten paired TMS pulses (conditioning and test pulse) in an intermixed randomized order. Short interval cortical inhibition is measured with an Inter-stimulus Intervals (ISI) of 3 msec and a stimulator output of 80% RMT for the conditioning stimulus and 1mVT stimulation intensity for the test stimulus. ICF investigation is measured with an ISI of 13 msec), with the condition of an ISI of 50 msec (ISI 50) and both stimuli applied with 1mVT intensity). Long Interval Cortical Inhibition (LICI) is measured with ISIs of 100 msec (ISI 100), 200 msec (ISI 200), and 300 msec (ISI 300); both stimuli with 1mVT intensity

methylphenidate tablets (10mg), ADHD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-IV diagnosis of Methamphetamine abuse co morbid with ADHD
• Right handedness

You may not qualify if:

• Other current Axis I disorders (except simple phobia and nicotine addiction)
• Personal or close family history of seizure disorder
• Ferromagnetic material in body or close to head
• Neurologic disorder
• Pregnancy
• Taking medications known to lower seizure threshold (eg, theophylline)

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Javad Alaghband-rad

Tehran University of Medical Sciences, Tehran Province, Iran

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., MPH.

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: July 26, 2012
• Study Start: September 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: March 1, 2016
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

IR (1)