Non Invasive Brain Stimulation Effects on Attentional Performance in ADHD Adults

NCT02286349 | Completed DMC

• 1 other identifier: ADHD_ brain stimulation_adults
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Conditions

Attention Deficit/Hyperactivity Disorder

Keywords

Neuromodulation Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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)

  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 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 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

Study Arms (4)

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).

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)

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).

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)

Device: Transcranial direct current stimulation (Soterix, USA)

Interventions

Transcranial magnetic stimulation (Neurosoft®) DEVICE

Repetitive transcranial magnetic stimulation

Real rTMS group; Sham rTMS group

Transcranial direct current stimulation (Soterix, USA) DEVICE

Transcranial direct current stimulation

Real tDCS group; Sham tDCS group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Transcranial Magnetic Stimulation; Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Kátia Monte-Silva, PHD

  Applied Neuroscience Laboratory, Universidade Federal de Pernambuco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 7, 2014
• Study Start: September 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 6, 2020

Record last verified: 2020-05