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Non Invasive Brain Stimulation Effects on Attentional Performance in ADHD Adults

Primary Purpose

Attention Deficit/Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcranial magnetic stimulation (Neurosoft®)
Transcranial direct current stimulation (Soterix, USA)
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Attention Deficit/Hyperactivity Disorder focused on measuring Neuromodulation Attention Deficit Hyperactivity Disorder

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Sham Comparator

    Experimental

    Sham Comparator

    Arm Label

    Real rTMS group

    Sham rTMS group

    Real tDCS group

    Sham tDCS group

    Arm Description

    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).

    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)

    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).

    Submitted to 20 minutes of neuropsychological assessment (on average) + 10 minutes of sham transcranial direct current stimulation + 20 minutes of neuropsychological reassessment (on average)

    Outcomes

    Primary Outcome Measures

    Digit Span (forward and backward)
    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

    D2 test
    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
    Trail Making Test (A and B)
    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.
    Digit Symbol Modality Test
    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.
    AC Test
    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

    Full Information

    First Posted
    November 4, 2014
    Last Updated
    May 4, 2020
    Sponsor
    Universidade Federal de Pernambuco
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02286349
    Brief Title
    Non Invasive Brain Stimulation Effects on Attentional Performance in ADHD Adults
    Official Title
    Effects of Noninvasive Brain Stimulation on Attentional Performance of Adults With Symptomatology of Attention Deficit Hyperactivity Disorder (ADHD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (Actual)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal de Pernambuco

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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
    Detailed Description
    The sample will be divided into four groups: (i) Experimental tDCS; (ii) Experimental rTMS; (iii) tDCS control; and rTMS control. The experimental groups consisted of subjects with ADHD symptomatology. Control groups were formed by healthy individuals. The subject will be considered healthy when there was no diagnosis of any DSM-IV psychiatric disorder and had symptoms with ADHD when there were frequent presence of at least six symptoms of inattention and / or symptoms of hyperactivity/impulsivity described by the Adult Self Report Scale (ASRS), a reliable tool for diagnosis of attention deficit / hyperactivity and validated for the Brazilian population. Both groups underwent two sessions of cortical stimulation: real (rTMS or tDCS) and sham. The order of sessions will be randomized and there will be a minimum interval of at last one week between sessions. Experimental Sessions Repetitive Transcranial Magnetic Stimulation (rTMS) With the individual seated comfortable, rTMS will be applied through a magnetic stimulator (Neurosoft®) using a figure-8 coil, positioned on the scalp at an angle of 45 degrees from the midline and pointing toward the anterior region of the skull. The area stimulated will be the left dorsolateral prefrontal cortex (DLPFC). Before applying rTMS over the DLPFC will be necessary to map the area of the representation of the FID by applying single pulses to measure the motor evoked potential (MEP) and resting motor threshold (RMT). The intensity adopted in real rTMS session will be 80% of the RMT. rTMS will be applied in just one session divided in to 5 blocks of stimulation. Each block will be separated by 5 minutes intervals. In each block 15 rTMS series of 1-second duration at 10 Hz frequency were applied. The interval between sets will be 10 seconds. The sham stimulation will be applied with the same settings real rTMS, but the coil will be not coupled to the magnetic stimulator, so the individual will be not able to differentiate the real session of sham. Transcranial Direct Current Stimulation (tDCS) Individuals will be instructed to sit in a chair and get a comfortable position. The continuous electrical current will be applied through a microcurrent stimulator (Soterix, USA). The surface electrodes used in all sessions of this study have dimensions of 5x7cm (35 cm2), were composed of electrically conductive rubber and wrapped in sponges soaked in saline. For the application of tDCS, the anode will be positioned on DLPFC and cathode in the contralateral supraorbital region. Parameters of intensity and stimulation duration of the current used were previously established in humans: intensity 1mA and duration of 10 minutes. In sham stimulation, sessions will use the same procedures of real tDCS application, however the stimulation device will be switched off five seconds after the start. Outcome measures - The subjects will be submitted an evaluation before (t0) the application of non-invasive cortical stimulation (active and sham) and immediately after (t1). These assessments consisted of neurocognitive tests that assess cognitive function and attention span of the patients. The tests will be applied (i) Trail Making Test (part A and B); (ii) digit span (forward and reverse order); (iii) digit symbol; (iv) C; (v) D2. Thus, the following items were assessed: (i) attentional focus (digit symbol, AC and trail making-part A); (ii) maintaining the attentional focus (D2 test); (iii) attentional span (digit span forward); (iv) the ability of mental manipulation (digit span backward and trail making test- part B); (v) ability to resist interference (D2 test). Neuropsychological assessment will be performed by a neuropsychology, blind to the type of experimental session (rTMS / or active tDCS / sham) to which the subject was submitted.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Attention Deficit/Hyperactivity Disorder
    Keywords
    Neuromodulation Attention Deficit Hyperactivity Disorder

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Real rTMS group
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Sham rTMS group
    Arm Type
    Sham Comparator
    Arm Description
    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)
    Arm Title
    Real tDCS group
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Sham tDCS group
    Arm Type
    Sham Comparator
    Arm Description
    Submitted to 20 minutes of neuropsychological assessment (on average) + 10 minutes of sham transcranial direct current stimulation + 20 minutes of neuropsychological reassessment (on average)
    Intervention Type
    Device
    Intervention Name(s)
    Transcranial magnetic stimulation (Neurosoft®)
    Intervention Description
    Repetitive transcranial magnetic stimulation
    Intervention Type
    Device
    Intervention Name(s)
    Transcranial direct current stimulation (Soterix, USA)
    Intervention Description
    Transcranial direct current stimulation
    Primary Outcome Measure Information:
    Title
    Digit Span (forward and backward)
    Description
    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.
    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
    Secondary Outcome Measure Information:
    Title
    D2 test
    Description
    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
    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
    Title
    Trail Making Test (A and B)
    Description
    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.
    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
    Title
    Digit Symbol Modality Test
    Description
    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.
    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
    Title
    AC Test
    Description
    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
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kátia Monte-Silva, PHD
    Organizational Affiliation
    Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Non Invasive Brain Stimulation Effects on Attentional Performance in ADHD Adults

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