Feasibility of Transcranial Direct Current Stimulation (tDCS) in the Treatment of Adult Attention Deficit Disorder (ADD).

NCT ID: NCT02206516

Last Updated: 2018-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2018-09-30

Brief Summary

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This study aims at combining imaging techniques and clinical evaluations to assess clinical change as well as brain changes that occur as a result of brain stimulation in adult attention deficit disorder.

Detailed Description

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This study will use clinical measures and cognitive tasks covering 3 different functional domains during functional magnetic resonance imaging (fMRI), ElectroEncephaloGram (EEG) and Ultrasound tagged near infrared spectroscopy (UT-NIRS), to assess functional brain changes as a result of a treatment protocol with Transcaranial direct current stimulation (tDCS) in adults suffering from attention deficit disorder (ADD).

Conditions

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Adult Attention Deficit Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patients

Stimulation using tDCS will be administered daily, 5 days a week for 4 weeks. each session will last 22 minutes during which the anode electrode will be positioned over the right Inferior Frontal Gyrus (IFG) and the Katode electrode over the right Orbito Frontal Gyrus (OFG).

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type DEVICE

Interventions

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Transcranial Direct Current Stimulation

Intervention Type DEVICE

Other Intervention Names

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neuroConn GmbH, Germany

Eligibility Criteria

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Inclusion Criteria

1. Patients between the ages of 18-65(male and female)
2. Diagnosed as suffering from Attention-Deficit Hyperactivity Disorder according to the DSM IV
3. Patients taking medication for ADHD will give their consent to stop those medication 48 before entering the study and throughout the daily treatments.
4. Gave informed consent for participation in the study
5. If referred by the treating psychiatrist, he or she approves of the subjects participation in the study

Exclusion Criteria

1. Suffering from other diagnosis on axis 1
2. History of drug or alcohol abuse during the last year
3. Inability to achieve satisfying level of communication with the subject
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ElMindA Ltd

INDUSTRY

Sponsor Role collaborator

Brainsway

INDUSTRY

Sponsor Role collaborator

Ornim Medical Ltd.

INDUSTRY

Sponsor Role collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Talma Hendler, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

TASMC

Locations

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TASMC

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0214-14

Identifier Type: -

Identifier Source: org_study_id

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