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Efficacy of Repetitive Transcranial Magnetic Stimulation in Adult Attention Deficit Disorder

Primary Purpose

Attention Deficit Disorder, ADHD

Status

Completed

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

repetitive Transcranial Magnetic Stimulation

About this trial

This is an interventional treatment trial for Attention Deficit Disorder focused on measuring rTMS, ADHD, ADD, fMRI

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Normal intelligence level (>90) Diagnosis of ADD by a psychiatrist using the ADHD-RS-IV with Adult Prompts Exclusion Criteria: Scores of 21 or more on BDI and/or BAI History of head trauma History of a major psychological or neurological condition Presence of metal in the head History of seizures Serious cardiovascular disease Use of medications with an impact on cognitive functions during the treatment window (patients with a constant and stable dose were included) Recent use of alcohol or substance abuse

Sites / Locations

National Brain Mapping Lab

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active rTMS

Arm Description

Participants in this one and only arm in the current study received active repetitive transcranial magnetic stimulation.

Outcomes

Primary Outcome Measures

Change in performance

Shortened version (4 min) of the continuous go/no-go task: gradual-onset continuous performance task (gradCPT)

Secondary Outcome Measures

Change in self-report attention scores

The 6-item ASRS-V1.1 Adult ADHD Self-Report

Change in investigator-rated attention scores

Investigator-Rated Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV (I-ADHD RS-IV) with adult prompts

Full Information

NCT ID

NCT06030024

First Posted

September 1, 2023

Last Updated

September 12, 2023

Sponsor

University of Tehran

1. Study Identification

Unique Protocol Identification Number

NCT06030024

Brief Title

Efficacy of Repetitive Transcranial Magnetic Stimulation in Adult Attention Deficit Disorder

Official Title

An Open-lable Investigation of the Effect of rTMS on Attention in an Adult Sample Suffering From ADD

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

September 1, 2021 (Actual)

Primary Completion Date

February 1, 2023 (Actual)

Study Completion Date

March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Tehran

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the current open-lable study was to use low-frequency repetitive transcranial magnetic stimulation (rTMS) to improve the attention deficits in a sample of adult patients suffering from attention deficit disorder. Participants received 10 sessions of rTMS over Fz (located using the EEG 10-20 international system) and underwent assessments of their attentional capacity using the gradCPT task in an fMRI scanner, before and after the intervention. Other behavioral assessments of their attention symptoms have also been conducted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Disorder, ADHD

Keywords

rTMS, ADHD, ADD, fMRI

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active rTMS

Arm Type

Experimental

Arm Description

Participants in this one and only arm in the current study received active repetitive transcranial magnetic stimulation.

Intervention Type

Device

Intervention Name(s)

repetitive Transcranial Magnetic Stimulation

Intervention Description

Magnetic pulses delivered to the Fz area of the brain in a low frequency (1 Hz) manner.

Primary Outcome Measure Information:

Title

Change in performance

Description

Shortened version (4 min) of the continuous go/no-go task: gradual-onset continuous performance task (gradCPT)

Time Frame

Up to 10 days, i.e., before and after the completion of the 10 sessions of rTMS

Secondary Outcome Measure Information:

Title

Change in self-report attention scores

Description

The 6-item ASRS-V1.1 Adult ADHD Self-Report

Time Frame

Baseline, after 5 days of stimulation, after 10 days of stimulation; Range= 0-6; Higher scores represent worse outcome

Title

Change in investigator-rated attention scores

Description

Investigator-Rated Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV (I-ADHD RS-IV) with adult prompts

Time Frame

Baseline, after 5 days of stimulation, after 10 days of stimulation; Range:0 - 54; Higher scores represent worse outcome

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Reza Rostami, M.D

Organizational Affiliation

University of Tehran

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Fatemeh Soltani, MSc

Organizational Affiliation

University of Tehran

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Brain Mapping Lab

City

Tehran

ZIP/Postal Code

1439957131

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Efficacy of Repetitive Transcranial Magnetic Stimulation in Adult Attention Deficit Disorder

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