Efficacy of Repetitive Transcranial Magnetic Stimulation in Adult Attention Deficit Disorder

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06030024
• Other study ID #: Attention
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: September 2023
• Source: University of Tehran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder
• Attention Deficit Disorder with Hyperactivity

Intervention

Device:
• repetitive Transcranial Magnetic Stimulation
Magnetic pulses delivered to the Fz area of the brain in a low frequency (1 Hz) manner.

Locations

Country	Name	City	State
Iran, Islamic Republic of	National Brain Mapping Lab	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
University of Tehran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in self-report attention scores	The 6-item ASRS-V1.1 Adult ADHD Self-Report	Baseline, after 5 days of stimulation, after 10 days of stimulation; Range= 0-6; Higher scores represent worse outcome
Secondary	Change in investigator-rated attention scores	Investigator-Rated Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV (I-ADHD RS-IV) with adult prompts	Baseline, after 5 days of stimulation, after 10 days of stimulation; Range:0 - 54; Higher scores represent worse outcome