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NCT Number: NCT05393739

Effect of Transcranial Magnetic Stimulation on Visual Functions of Adult Amblyopia: a Preliminary Study

Amblyopia, with a prevalence rates of 3% in adult population, is a common cause of vision impairment. It is characterized by impaired vision in one or both eyes because of disruption of normal visual stimuli and underdevelopment of the visual cortex, leads to lifelong visual deficits affecting both monocular and binocular visual function. Common causes of amblyopia include refraction error, anisometropia, strabismus and visual deprivation arising from ptosis or congenital cataract. Our previous studies had shed light on the relationship between abnormal early visual experience, and development of later amblyopia and possible neural developmental disorders. Functional recovery is difficult when neuroplasticity slows down at the end of the critical period. To date, there is no established effective treatment for adult amblyopia.

Repetitive transcranial magnetic stimulation (rTMS) is one of the non-invasive stimulations had been used widely as a research tool to understand the brain functions and an established treatment modality in neuropsychiatric diseases. Theta burst stimulation (TBS) is a newer form of rTMS protocol which have a major advantage over traditional rTMS in their reduced administration duration and allowing stimulation at significantly lower intensities to attain comparable effects. TBS had been demonstrated to able to improve functions in participants with visual disorders. However, studies of its use on adult amblyopia are scarce. Due to lack of efficient treatment at present, it is of scientific significance to conduct placebo-controlled experiments on this topic. Investigators will evaluate the effect of three regimens of TBS (intermittent, continuous and sham), after one session and accumulative sessions, on visual functions of amblyopia adults shortly after treatment and 2 weeks later (lasting effect), in order to evaluate its potential role in amblyopia and find out the best paradigm for amblyopia treatment.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei County, 100225, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult amblyopia participants, aged 20-50 years old.
  • Based on inclusion criteria, there was a minimum of 2 lines difference in BCVA between the 2 eyes.
  • An amblyogenic factor and history of amblyopia treatment was recorded

Exclusion criteria

  • Unstable vital sign
  • History of brain injury and/or head trauma
  • Neurological and psychiatric disease
  • Seizures or family history of seizure
  • Pregnancy
  • Uncontrolled migraine or the presence of metallic implants or shunt in the head or torso
  • Wide region of ischemic cicatrix, multiple sclerosis, taking tricycle antidepressants,
  • Analgesics or any drugs may decrease the threshold for inducing seizure
  • Experienced sleep disorders during the rTMS treatment
  • Severe alcoholism or taking seizure drugs
  • Severe heart diseases or uncontrollable migraine caused by high intracranial pressure

Treatment and study plan

Theta burst transcranial magnetic stimulation (TBS) procedure

Device

The procedure includes determining the specific occipital point at which place the stimulation coil; this corresponds to the area where magnetic stimulation is most capable of inducing phosphenes or transient visual phenomena. The phosphenes are directly induced by stimulation of the visual cortex and their presence indicates that the magnetic stimulation is in the correct location. The subjects would wear a personalized swimming cap with the determined area for stimulation marked on it. The major differences between iTBS and cTBS are the frequency and interval of stimulus.

Primary outcomes

  1. Objective

    Time frame: 1 month for each participant

    Change from baseline best corrected visual acuity: distance visual acuity measured for each eye at a distance of 6 m. Visual acuity scored letter-by-letter instead and lonarithm of the minimum angle of resolution (logMAR) scores were recored.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
May 26, 2022
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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