Clinical trial NCT05393739: Effect of Transcranial Magnetic Stimulation on Visual Functions of Adult Amblyopia: a Preliminary Study
Official title: Effect of Transcranial Magnetic Stimulation on Visual Functions of Adult Amblyopia: a Preliminary Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amblyopia
Keywords: Transcranial magnetic stimulation
Amblyopia
Neuroplasticity
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Objective
timeFrame: 1 month for each participant
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Tzu-Hsun Tsai
role: PRINCIPAL_INVESTIGATOR
References: