Effects of Transcranial Photobiomodulation in ADHD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-44
SponsorFrancisco Gonzalez-Lima, PhD
About this trial
The investigators have previously shown that non-invasive methods of brain stimulation such as the administration of transcranial infrared light to the prefrontal cortex (PFC) can result in improvements to cognition and emotion as well as brain oxygenation. This method is called transcranial photobiomodulation (tPBM).
The investigators hypothesize that tPBM can improve cognition and brain oxygenation in adults with attention deficit hyperactivity disorder (ADHD). The investigators will investigate the effects of repeated tPBM sessions on cognitive functioning in adults with ADHD. Specifically, the investigators hypothesize that participants that receive tPBM will show improvements in response control, sustained attention, and working memory, as well as improvements in prefrontal hemodynamics and a reduction in ADHD symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
English-speaking
Adults of any sex
Age range: 18-44 years
Any ethnic/racial background
Disqualifiers
Currently pregnancy
Any sham or active photobiomodulation treatment within the past five weeks.
Trial design
Design model
Parallel
Treatments tested in this trial
Active transcranial photobiomodulation
DeviceActive transcranial photobiomodulation to the forehead targeting prefrontal cortex involves administration of 1064-nm light delivered via laser with a 4 centimeter beam diameter and 250 mW/cm2 power density for 8 minutes per treatment.
Sham transcranial photobiomodulation
DeviceIdentical procedure as active group, but without 1064-nm light emitted by the device.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Active transcranial photobiomodulationActive comparator 1 intervention
Group B: Sham transcranial photobiomodulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Performance on the Continuous Performance Task
The Continuous Performance Task is a widely-used cognitive measure to evaluate sustained attention, vigilance, and response control. Participants respond to letters presented on a computer screen and inhibit their responses to the letter X. There is no score on a scale. An increase in Correct Rejections on CPT = better inhibition = better outcome of treatment.
Time frame
1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3).2
Prefrontal oxygenation (functional near-infrared spectroscopy)
Participants will wear a head-mounted functional near-infrared spectroscopy device that records changes in the concentrations of oxygenated hemoglobin potentially resulting from the treatment.
Time frame
1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3).3
Scores on the Adult ADHD Self-Report Scale (ASRS) questionnaire
The ASRS is an 18-question self-assessment tool created by the World Health Organization (WHO) which evaluates symptom severity of ADHD. Minimum score=18; maximum score=90; high score = more ADHD symptoms; lower score after treatment = better outcome.
Time frame
1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3). 3. Follow-up: Four weeks later (Online).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Francisco Gonzalez-Lima, PhD
Lead sponsor
University of Texas at Austin
Sponsor institution
Source ClinicalTrials.gov