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Accelerated and Extended-iTBS Targeting Inhibitory Control in Veterans With ADHD

ConditionAttention Deficit Disorder With Hyperactivity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVA Office of Research and Development

About this trial

Impaired inhibitory response manifests clinically as increased impulsivity, which leads to poorer affective, cognitive, social, and occupational functioning. Neuropsychiatric disorders prevalent among Veterans, such as Attention Deficit/Hyperactivity Disorder (ADHD), are associated with poor inhibitory control. The mainstay of clinical treatment for ADHD is psychostimulants, yet these medications have significant risks, including dependence and numerous side effects. Thus, novel and non-pharmacological therapeutic strategies are needed. Intermittent Theta Burst Stimulation, a newer form of transcranial magnetic stimulation, has emerged as a promising tool for modulating inhibitory neuronal circuits. This research proposal will investigate the feasibility and acceptability of iTBS on inhibitory control and impulsivity through a randomized controlled trial to inform clinical observations. The long-term goal is to improve impulsivity, social and occupational functioning, and enhance the quality of life for Veterans.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of attention-deficit/hyperactivity disorder (ADHD) predominantly hyperactive-impulsive or combined, as outlined in the DSM-5-TR criteria

Maintenance of clinical symptoms despite receiving stable treatment for a minimum of 6 weeks before the study procedures

Capability to comprehend and provide informed consent

For safety reasons, participants must meet established screening criteria to ensure safety during Magnetic Resonance Imaging (MRI) scans

Disqualifiers

Primary psychotic disorders, bipolar I disorder, ongoing severe substance use disorders, or active suicidality

Non-MRI safe cardiac pacemakers, implanted devices, or metallic implants at the upper thoracic spine level or higher

pregnancy

lactation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intermittent Theta-Burst Stimulation

    Device

    Theta Burst Stimulation is a second-generation TMS modality. iTBS enhances cortical excitability, facilitating synaptic connections through putative long-term potentiation-like effects. In addition, iTBS also stands out given its favorable safety profile and its brief administration time.

  • Sham Stimulation

    Device

    Sham will be administered using equivalent procedures but with a sham coil.

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: Active StimulationActive comparator 1 intervention
Group B: Sham StimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility measured by follow-up completion

Feasibility will be determined through follow-up completion. This will be calculated as simple proportion based on attended and scheduled follow-up sessions.

Time frame
6 weeks
2

Acceptability measured by stimulation sessions attendance

Acceptability will be measured based on stimulation session attendance. This will be calculated as simple proportion based on attended and scheduled iTBS sessions.

Time frame
1 day

Secondary outcomes

1

Impulsivity measured by Short Urgency-Premeditation-Perseverance-Sensation Seeking-Positive Urgency (SUPPS-P)

The SUPPS-P is a self-report 20-item questionnaire and will be applied to assess positive urgency, negative urgency, sensation seeking, lack of premeditation, and lack of perseverance.

Time frame
6 weeks
2

Impulsivity measured by the Barratt Impulsiveness Scale (BIS-11)

The BIS-11 is a self-report scale for the assessment of impulsivity that includes three constructs of impulsivity: motor, attention, and non-planning.

Time frame
6 weeks
3

Go/no-go task

This task will include 150 trials. Individuals will be asked to react by pressing a button as soon as a previously designated target (black square) is presented on the computer screen (go stimulus). No behavioral reaction is required when no-go stimuli (black circle) appear. All the stimuli will be displayed in black with a white background, with the same dimensions on the computer screen for 500ms, with 1000ms as the interstimulus interval (ISI). Commission errors, omission errors, and reaction time (RT) will be assessed.

Time frame
6 weeks
4

Stop-signal task

This task will include 150 trials, with the stimulus presented for 500ms, 1000ms ISI, and with 30% random presentation of the stop-signal. Veterans will be asked to press a specific button when a go stimulus (black circle with white arrow to the left or the right) is presented and will be requested to not click when a stop-signal (visual clue will be a red circle with white arrow to the right or the left) is shown at unpredictable intervals. The stop-signal reaction time (SSRT) and the inhibition rate (IR) will be evaluated.

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: