Trial of a non-invasive stimulation method to treat visual hallucinations in people with macular degeneratio

Not Applicable

Completed

• Conditions: Charles Bonnet Syndrome; Eye Diseases

• Registration Number: ISRCTN16758036
• Lead Sponsor: orthumberland Tyne & Wear NHS Trust

Brief Summary

2022 Results article in https://doi.org/10.1016/j.ophtha.2022.06.041 (added 26/01/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-29
• Study Completion: 2020-06-30
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

All participants:
1. Age >18, either sex
2. Provision of written informed consent
3. MMSE-blind >24
4. Absence of any concurrent major psychiatric illness (e.g. major depression) or dementia
5. Absence of severe physical illness or co-morbidity that may limit ability to fully participate in study
6. Sufficient English to allow assessment scales and cognitive testing

Charles Bonnet Syndrome:
1. Meet the diagnostic criteria of CBS: Cognitively intact, having complex visual hallucinations (with no hallucinations in other modalities or delusions), full insight into the unreality of these, and presence of eye disease sufficient to cause visual impairment
2. Evidence of persistent and recurrent episodes of visual hallucinations determined to be of stable frequency with the expectation of at least one hallucination per day

Control (eye disease):
1. Presence of eye disease sufficient to cause visual impairment
2. No prior history of visual hallucinations

Exclusion Criteria

All participants:
1. Skin allergies or sensitivities to electrode gels or any significant dermatological/scalp disease
2. Past history of excess alcohol intake
3. Past history of other neurological illness including, but not limited to, stroke, intracerebral pathology, and epilepsy
4. Metal or electronic implants (including pacemakers) which might be affected by strong magnetic fields (occurring in TMS or MR component of the study) or electrical currents (tDCS component)

Charles Bonnet Syndrome:
1. Psychotropic and other medications which may significantly interfere with cognitive testing and tDCS efficacy (including high dose antipsychotics, dopamine agonists, sedative antidepressants, benzodiazepines except when in low dose and used as hypnotics, and centrally acting anticholinergic drugs)
2. Evidence for Lewy body symptoms and signs which may cast doubt on a CBS diagnosis (i.e. REM sleep disorder).

Control (eye disease):
1. Past history of visual hallucinations

Study & Design

• Study Type: Interventional
• Study Design: Not specified