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Efficacy of Repetitive Transcranial Magnetic Stimulation in Adult Attention Deficit Disorder

Sponsor
University of Tehran (Other)
Overall Status
Completed
CT.gov ID
NCT06030024
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
17.9
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: repetitive Transcranial Magnetic Stimulation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-lable Investigation of the Effect of rTMS on Attention in an Adult Sample Suffering From ADD
Actual Study Start Date :
Sep 1, 2021
Actual Primary Completion Date :
Feb 1, 2023
Actual Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active rTMS

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

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

Outcome Measures

Primary Outcome Measures

  1. Change in performance [Up to 10 days, i.e., before and after the completion of the 10 sessions of rTMS]

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

Secondary Outcome Measures

  1. 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]

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

  2. 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]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Brain Mapping Lab Tehran Iran, Islamic Republic of 1439957131

Sponsors and Collaborators

  • University of Tehran

Investigators

  • Study Director: Reza Rostami, M.D, University of Tehran
  • Principal Investigator: Fatemeh Soltani, MSc, University of Tehran

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
reza kazemi, Assistant professor, University of Tehran
ClinicalTrials.gov Identifier:
NCT06030024
Other Study ID Numbers:
  • Attention
First Posted:
Sep 8, 2023
Last Update Posted:
Sep 14, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by reza kazemi, Assistant professor, University of Tehran
rTMS
ADHD
ADD
fMRI
Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Sep 14, 2023