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

Not Applicable

Recruiting

• Conditions: Amblyopia
• Interventions: Device: Theta burst transcranial magnetic stimulation (TBS) procedure

• Registration Number: NCT05393739
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-05-02
• Study First Submitted QC: 2022-05-25
• Study First Posted: 2022-05-26
• Study Start: 2023-01-05
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham theta burst	Theta burst transcranial magnetic stimulation (TBS) procedure	The stimulus intensity in sham group is about half of that in iTBS/cTBS groups, and the subjects receive a placebo stimulation with the coil orientation tilted to 90°. The visual function evaluation includes BCVA, contrast sensitivity and stereoacuity. Visual functions will be evaluated right after TBS session (t1). Participant will receive same type of treatment for another 2 times within one week followed by visual function tests (t2). To evaluate the long-term effect, participants will be followed for another visual function tests (t3) after 2 weeks.
Intermittent theta burst	Theta burst transcranial magnetic stimulation (TBS) procedure	The total TBS time is about 1 to 3 minutes and the subjects have to look at at a visual stimulus on a computer monitor while receiving TBS and continue the visual training until 20 minutes after the treatment. In iTBS group, the subjects look at the visual stimulus with amblyopic eye while in cTBS group, subjects look at visual stimulus with non-amblyopic eye. The subjects will receive three times of stimulations in one week. The visual function evaluation includes BCVA, contrast sensitivity and stereoacuity. Visual functions will be evaluated right after TBS session (t1). Participant will receive same type of treatment for another 2 times within one week followed by visual function tests (t2). To evaluate the long-term effect, participants will be followed for another visual function tests (t3) after 2 weeks.
Continuous theta burst	Theta burst transcranial magnetic stimulation (TBS) procedure	The total TBS time is about 1 to 3 minutes and the subjects have to look at at a visual stimulus on a computer monitor while receiving TBS and continue the visual training until 20 minutes after the treatment. In iTBS group, the subjects look at the visual stimulus with amblyopic eye while in cTBS group, subjects look at visual stimulus with non-amblyopic eye. The subjects will receive three times of stimulations in one week. The visual function evaluation includes BCVA, contrast sensitivity and stereoacuity. Visual functions will be evaluated right after TBS session (t1). Participant will receive same type of treatment for another 2 times within one week followed by visual function tests (t2). To evaluate the long-term effect, participants will be followed for another visual function tests (t3) after 2 weeks.

Primary Outcome Measures

Name	Time	Method
Objective	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei county, Taiwan