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

Amblyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05393739
• Other study ID #: 202106139DINC
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: National Taiwan University Hospital
• Contact: Tzu-Hsun Tsai, PhD
• Phone: 886223123456
• Email: lucia_tsai[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Amblyopia

Intervention

Device:
• Theta burst transcranial magnetic stimulation (TBS) procedure
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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei county

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective	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.	1 month for each participant