Overview

This trial is active, not recruiting.

Condition attention deficit/hyperactivity disorder
Treatments transcranial magnetic stimulation (neurosoft®), transcranial direct current stimulation (soterix, usa)
Phase phase 1/phase 2
Sponsor Universidade Federal de Pernambuco
Start date September 2014
End date August 2015
Trial size 12 participants
Trial identifier NCT02286349, ADHD_ brain stimulation_adults

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
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).
transcranial magnetic stimulation (neurosoft®)
Repetitive transcranial magnetic stimulation
(Sham Comparator)
Submitted to 20 minutes of neuropsychological assessment (on average) + 5 stimulation sham blocks, each block containing 15 series of epetitive transcranial magnetic stimulation with 1 second duration and presenting interval of 10 seconds between sets + 20 minutes of neuropsychological reassessment (on average)
transcranial magnetic stimulation (neurosoft®)
Repetitive transcranial magnetic stimulation
(Experimental)
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).
transcranial direct current stimulation (soterix, usa)
Transcranial direct current stimulation
(Sham Comparator)
Submitted to 20 minutes of neuropsychological assessment (on average) + 10 minutes of sham transcranial direct current stimulation + 20 minutes of neuropsychological reassessment (on average)
transcranial direct current stimulation (soterix, usa)
Transcranial direct current stimulation

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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
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
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
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

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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

Additional Information

Official title Effects of Noninvasive Brain Stimulation on Attentional Performance of Adults With Symptomatology of Attention Deficit Hyperactivity Disorder (ADHD)
Principal investigator Kátia Monte-Silva, PHD
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 confortably, 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 submited 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) attencional focus (digit symbol, AC and trail making-part A); (ii) maintaining the attencional focus (D2 test); (iii) attentional span (digit span foward); (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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Universidade Federal de Pernambuco.