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Non Invasive Brain Stimulation Effects on Attentional Performance in ADHD Adults

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ClinicalTrials.gov Identifier: NCT02286349
Recruitment Status : Unknown
Verified November 2014 by Kátia Monte-Silva, Universidade Federal de Pernambuco.
Recruitment status was:  Active, not recruiting
First Posted : November 7, 2014
Last Update Posted : April 13, 2015
Sponsor:
Information provided by (Responsible Party):
Kátia Monte-Silva, Universidade Federal de Pernambuco

Brief Summary:
This study aims to evaluate the effect of noninvasive brain stimulation in adults with ADHD symptomatology compared them with healthy adults. For this, volunteers will allocate into two groups (experimental and control), will pass through session two types of transcranial stimulation: Repetitive Transcranial MagneticsStimulation (rTMS) and transcranial direct current stimulation (tDCS); considering two session types (real and sham). Attentional assessment will be carried out through specific neurocognitive tests applied before and after each session of stimulation

Condition or disease Intervention/treatment Phase
Attention Deficit/Hyperactivity Disorder Device: Transcranial magnetic stimulation (Neurosoft®) Device: Transcranial direct current stimulation (Soterix, USA) Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Noninvasive Brain Stimulation on Attentional Performance of Adults With Symptomatology of Attention Deficit Hyperactivity Disorder (ADHD)
Study Start Date : September 2014
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Real rTMS group
Submitted to 20 minutes of neuropsychological assessment (on average) + 5 blocks of real stimulation intensity of 10 Hz, each block containing 15 series of repetitive transcranial magnetic stimulation with 1 second duration and presenting interval of 10 seconds between sets + 20 minutes of neuropsychological reassessment (on average).
Device: Transcranial magnetic stimulation (Neurosoft®)
Repetitive transcranial magnetic stimulation

Sham Comparator: Sham rTMS group
Submitted to 20 minutes of neuropsychological assessment (on average) + 5 stimulation sham blocks, each block containing 15 series of repetitive transcranial magnetic stimulation with 1 second duration and presenting interval of 10 seconds between sets + 20 minutes of neuropsychological reassessment (on average)
Device: Transcranial magnetic stimulation (Neurosoft®)
Repetitive transcranial magnetic stimulation

Experimental: Real tDCS group
Submitted to 20 minutes of neuropsychological assessment (on average) + 10 minutes of real anodal transcranial direct current stimulation with intensity of 1 mA + 20 minutes of neuropsychological reassessment (on average).
Device: Transcranial direct current stimulation (Soterix, USA)
Transcranial direct current stimulation

Sham Comparator: Sham tDCS group
Submitted to 20 minutes of neuropsychological assessment (on average) + 10 minutes of sham transcranial direct current stimulation + 20 minutes of neuropsychological reassessment (on average)
Device: Transcranial direct current stimulation (Soterix, USA)
Transcranial direct current stimulation




Primary Outcome Measures :
  1. Digit Span (forward and backward) [ Time Frame: The test will be administered before and after each stimulation session for all groups involved in the research. The stimulation sessions present an interval of one week. The whole rTMS session will last 30 minutes and the tDCS session of 10 minutes. The ]
    The digit span forward contains eight items of sequence numbers that should be recalled in direct order after reading the examiner and digit span backward contains seven items of sequences of numbers that should be recalled in reverse order. Both are interrupted when two sequences of the same item number is wrong.


Secondary Outcome Measures :
  1. D2 test [ Time Frame: The test will be administered before and after each stimulation session for all groups involved in the research. The stimulation sessions present an interval of one week. The whole rTMS session will last 30 minutes and the tDCS session of 10 minutes. The ]
    Characterized as a test of concentrated visual attention and in the broadest sense, the ability to concentrate. It consists of 14 lines, the subjects must identify and scratch at each line the letters "d" having two lines, having a time limit of 20 seconds to complete each line

  2. Trail Making Test (A and B) [ Time Frame: The test will be administered before and after each stimulation session for all groups involved in the research. The stimulation sessions present an interval of one week. The whole rTMS session will last 30 minutes and the tDCS session of 10 minutes. The ]
    Participants are required to draw a line connecting numbered circles in a sequential order in part A. In part B the same task is performed, however, the participant must connect numbered and lettered circles in alternating sequential-alphabetical order. The TMT is presented as a measure of attention, processing speed and mental flexibility.

  3. Digit Symbol Modality Test [ Time Frame: The test will be administered before and after each stimulation session for all groups involved in the research. The stimulation sessions present an interval of one week. The whole rTMS session will last 30 minutes and the tDCS session of 10 minutes. The ]
    The SDMT requires individuals to identify nine different symbols corresponding to the numbers 1 through 9, and to practice writing the correct number under the corresponding symbol. Then they manually fill the blank space under each symbol with the corresponding number. It is a test used to investigate divided attention, visual tracking and motor processing speed.

  4. AC Test [ Time Frame: The test will be administered before and after each stimulation session for all groups involved in the research. The stimulation sessions present an interval of one week. The whole rTMS session will last 30 minutes and the tDCS session of 10 minutes. The ]
    The test aims at maintaining concentrated attention at work. The test consists of 21 lines, each having 21 symbols so that each line should be canceled whenever 7 symbols. The stimuli that must be canceled are found in a rectangle on top of the sheet



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Experimental group Punctuate 6 items or more (in the "frequently" and / or "quite often" on the Adult Self Report Scale (ASRS-18).

  • Control group Punctuate fewer than six items (in the "frequently" and / or "quite often" on Adult Self Report Scale (ASRS-18) Not exhibit symptoms of other disorders measured by the Mini International Neuropsychiatric Interview (M.I.N.I).

Exclusion Criteria:

  • epilepsy;
  • neurosurgery (including implant metal clips);
  • head trauma;
  • implantation of a pacemaker;
  • current use of epileptogenic drugs;
  • uncontrolled severe organic disease.
  • pregnancy.
  • current use of psychostimulant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02286349


Sponsors and Collaborators
Universidade Federal de Pernambuco
Investigators
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Principal Investigator: Kátia Monte-Silva, PHD Applied Neuroscience Laboratory, Universidade Federal de Pernambuco

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Responsible Party: Kátia Monte-Silva, PHD, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT02286349     History of Changes
Other Study ID Numbers: ADHD_ brain stimulation_adults
First Posted: November 7, 2014    Key Record Dates
Last Update Posted: April 13, 2015
Last Verified: November 2014

Keywords provided by Kátia Monte-Silva, Universidade Federal de Pernambuco:
Neuromodulation Attention Deficit Hyperactivity Disorder

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms