Brain stimulation of the cerebellum for balance and thinking in older people with glaucoma

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for right-handed adults over 55 with glaucoma in both eyes, to test brain stimulation of the cerebellum for balance and thinking.

Age

Over 55 years old

Sex

All sexes can join.

Disease stage

Primary open-angle or normal-tension glaucoma in both eyes, with visual field loss (mean deviation of ≤- 6 dB on the Humphrey 24-2 test) and distance vision of 6/12 (0.3 logMAR) or better.

Biomarker or test result

A score of 22 or above on the Montreal Cognitive Assessment (HK-MoCA). Right-handed, checked with the Edinburgh Handedness Inventory.

Main reasons for not taking part

• Bone, muscle or nerve diseases that can affect balance
• Eye diseases other than glaucoma (for example macular degeneration, diabetic retinopathy, moderate to severe cataract)
• Severe hearing problems
• Any reason that makes tES unsafe

The registry criteria, word for word

What the trial wants to find out

The goal of this clinical trial is to use different tES techniques to constantly stimulate the cerebellum in older glaucoma patients. The main questions aim to answer :

The 3 groups in the trial

• tDCSTreatment being tested

  The tDCS stimulation session will be performed over five consecutive days. The tDCS protocol used in this study will involve the application of a low direct current of 2 mA for 20 minutes using a Nurostym tES device (Neuro Device Group SA, Poland). It begins with a 30-second ramp-up period and employs two 5 cm × 5 cm electrodes that are housed in saline-soaked sponges. The anode and the cathode electrodes will be placed bilaterally over the cerebellum (1 cm below the inion of the occipital bone) and the right shoulder, respectively. This electrode montage is based on previous studies and is designed to target cerebellar regions implicated in balance and motor control.

  Treatment: transcranial electrial stimulation

• tACSTreatment being tested

  The tACS stimulation session will be five consecutive days. tACS protocol used in the study will be delivered using the Neurostym tES device (Neuro Device Group SA, Poland) with two 5 × 5 cm electrodes. The anode and the cathode electrodes will be placed bilaterally over the cerebellum (1 cm below the inion of the occipital bone) and the right shoulder, respectively. The tACS will be administered at a current of 2 mA with a stimulation frequency of 50 Hz. There will be a 30-second ramp-up and ramp-down period to minimize discomfort at the onset and offset of stimulation.

  Treatment: transcranial electrial stimulation

• ShamSham treatment, for comparison

  The sham protocol will mimic the same electrode placement as the other experimental group setting to maintain blinding. During sham stimulation, the stimulator will deliver 2 mA current for the first 30 seconds, after which the current will be turned off for the remainder of the session. To further enhance blinding, the current will be reactivated at 2 mA for the final 30 seconds of the stimulation and then gradually taper off thereafter. The total duration of the sham stimulation will match that of the active stimulation protocols (20 minutes). Each stimulation session will be five consecutive days.

  Treatment: transcranial electrial stimulation