Efficacy of Repetitive Transcranial Magnetic Stimulation in Adult Attention Deficit Disorder

NCT06030024 | Completed

• 1 other identifier: Attention
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Disorder; ADHD

Keywords

rTMS; ADHD; ADD; fMRI

Outcome Measures

Primary Outcomes (1)

• Change in performance

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

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

Secondary Outcomes (2)

• Change in self-report attention scores

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

• Change in investigator-rated attention scores

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

Study Arms (1)

Active rTMS

EXPERIMENTAL

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

Device: repetitive Transcranial Magnetic Stimulation

Interventions

repetitive Transcranial Magnetic Stimulation DEVICE

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

Active rTMS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Normal intelligence level (\>90)
• Diagnosis of ADD by a psychiatrist using the ADHD-RS-IV with Adult Prompts

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tehran: lead

Study Sites (1)

National Brain Mapping Lab

Tehran, 1439957131, Iran

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Reza Rostami, M.D

  University of Tehran

  STUDY DIRECTOR

• Fatemeh Soltani, MSc

  University of Tehran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: September 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)