NCT02206516

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

March 8, 2018

Status Verified

March 1, 2018

Enrollment Period

3.2 years

First QC Date

July 28, 2014

Last Update Submit

March 7, 2018

Conditions

Adult Attention Deficit Disorder

Outcome Measures

Primary Outcomes (1)

  • Efficacy will be examined by the change in the CAARS questionnaire from the baseline visit to the determination visit in the treatment group compared to the control group.

    6 weeks

Secondary Outcomes (1)

  • changes in functional activity after 4 weeks of tDCS treatment during response inhibition

    6 weeks

Study Arms (1)

patients

EXPERIMENTAL

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).

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current StimulationDEVICE
Also known as: neuroConn GmbH, Germany
patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Suffering from other diagnosis on axis 1
  • History of drug or alcohol abuse during the last year
  • Inability to achieve satisfying level of communication with the subject

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TASMC

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Talma Hendler, MD, PhD

    TASMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2014

First Posted

August 1, 2014

Study Start

July 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2018

Last Updated

March 8, 2018

Record last verified: 2018-03

Locations

IL(1)