Attention Deficit/Hyperactivity DisorderNCT02286349
Non Invasive Brain Stimulation Effects on Attentional Performance in ADHD Adults
A study testing Transcranial magnetic stimulation (Neurosoft®) and Transcranial direct current stimulation (Soterix, USA) in people with Attention Deficit/Hyperactivity Disorder, run by Universidade Federal de Pernambuco.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit/Hyperactivity Disorder
- What is being tested?
- Transcranial magnetic stimulation (Neurosoft®) and Transcranial direct current stimulation (Soterix, USA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
About this study
Official title: Effects of Noninvasive Brain Stimulation on Attentional Performance of Adults With Symptomatology of Attention Deficit Hyperactivity Disorder (ADHD)
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
Read the 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.
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Being tested
- Transcranial magnetic stimulation (Neurosoft®), Transcranial direct current stimulation (Soterix, USA)
- Keywords
- Neuromodulation Attention Deficit Hyperactivity Disorder
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulation (Neurosoft®)Device
Repetitive transcranial magnetic stimulation
Transcranial direct current stimulation (Soterix, USA)Device
Transcranial direct current stimulation
| Study group | Role | What they receive |
|---|---|---|
| Real rTMS group | 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). Receives: Device: Transcranial magnetic stimulation (Neurosoft®) |
| Sham rTMS group | Sham comparator | 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) Receives: Device: Transcranial magnetic stimulation (Neurosoft®) |
| Real tDCS group | 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). Receives: Device: Transcranial direct current stimulation (Soterix, USA) |
| Sham tDCS group | 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) Receives: Device: Transcranial direct current stimulation (Soterix, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (4)
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
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kátia Monte-Silva, Universidade Federal de Pernambuco
- Investigators
- Kátia Monte-Silva, PHD, Principal investigator, Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286349
- Sponsor's protocol ID
- ADHD_ brain stimulation_adults
- Status last verified
- May 2020
- First submitted
- 4 Nov 2014
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Noninvasive Brain Stimulation on Attentional Performance of Adults With Symptomatology of Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT02286349
- Acronym / sponsor ID
- ADHD_ brain stimulation_adults
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Keywords
- Neuromodulation Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Real rTMS group | Experimental | Device: Transcranial magnetic stimulation (Neurosoft®)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). |
| Sham rTMS group | Sham comparator | Device: Transcranial magnetic stimulation (Neurosoft®)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) |
| Real tDCS group | Experimental | Device: Transcranial direct current stimulation (Soterix, USA)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). |
| Sham tDCS group | Sham comparator | Device: Transcranial direct current stimulation (Soterix, USA)Submitted to 20 minutes of neuropsychological assessment (on average) + 10 minutes of sham transcranial direct current stimulation + 20 minutes of neuropsychological reassessment (on average) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (8 listed)
- epilepsy;
- neurosurgery (including implant metal clips);
- head trauma;
- implantation of a pacemaker;
- current use of epileptogenic drugs;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulation (Neurosoft®)Repetitive transcranial magnetic stimulation | Device | Real rTMS group, Sham rTMS group |
| Transcranial direct current stimulation (Soterix, USA)Transcranial direct current stimulation | Device | Real tDCS group, Sham tDCS group |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kátia Monte-Silva, PHD principal investigator
Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation (Neurosoft®) and Transcranial direct current stimulation (Soterix, USA) in people with Attention Deficit/Hyperactivity Disorder, run by Universidade Federal de Pernambuco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.