Topic: Dementias and Neurodegenerative Diseases Research Network
Conditions
Interventions
Transcranial Direct Current Stimulation (tDCS). This involves the application of a weak electrical current (<2mA) between two scalp surface electrodes. Participants will either receive active or sham
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age > 60, either sex 2. Provision of written informed consent or, if lacking capacity, consent provided by legal or other appropriate representative in accordance with provisions of the 2005 Mental Capacity Act 3. Absence of concurrent major psychiatric illness (e.g. major depression) 4. Absence of severe physical illness or comorbidity that may limit ability to fully participate in study 5. Sufficient English to allow assessment scales and cognitive testing For Lewy body dementia participants: 1. MMSE>12 2. Meet criteria for probable DLB or probably PDD 3. If taking anticholinesterase drugs, memantine, antipsychotic medication and/or antiparkinsonian medication ? need to be stable on these agents for at least 1 month 4. Presence of reliable informant sufficient to provide information for informant rated scales 5. Evidence of persistent and recurrent visual hallucinations of a moderate to severe nature occurring in the month prior to inclusion in the study
Exclusion criteria
Exclusion criteria: 1. Skin allergies or sensitivities to electrode gels or any significant dermatological / scalp disease 2. Past history excess alcohol intake 3. History of moderate to severe visual impairment secondary to glaucoma, cataract, or macular degeneration 4. Metallic implants in the head/neck area or electronic implants of any kind (including pacemakers) 5. Past history of other neurological illness including, but not limited to stroke, intracerebral pathology and epilepsy 6. Psychotropic and other medications which may significantly interfere with cognitive testing and tDCS efficacy (including high dose antipsychotics, dopamine agoinsts, sedative antidepressants, benzodiazepines except when low dose and used as hypnotics or treatment for REM-sleep behaviour disorder and centrally acting anticholinergic drugs)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The acute benefits of tDCS treatment on visual hallucinations at Day 5 2. The chronic benefits of tDCS as assessed at one and three months. The measure used for the severity and frequency of visual hallucinations will be the composite score derived from question 2 of the neuropsychiatric inventory (NPI). This measure normally assesses hallucination occurrence over the previous month, so the question will be modified for the acute assessment (Day 5) to ask about hallucination frequency and severity over the 4 days of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The Neuropsychiatric Inventory (NPI) hallucinations subscale will be used to assess maintenance of any benefit at 3 months follow-up. Two other visual hallucination scales (NEVI-H and the Neuropsychiatric Inventory ? Clinician (NPI-C) hallucination severity score) will be used as secondary measures of visual hallucinations at each of the assessment time points (Day 5, 1 month and 3 months). 2. Other secondary measures will include changes in visuo-perceptual function (following treatment), global measures of neuropsychiatric symptom severity (NPI), as well as cognitive and quality of life indexes. The clinician global impression of scale change will also be used as a general marker of improvement or deterioration at 1 month and 3 months. As a biomarker measure of response, the repeat phosphene excitability measure at Day 5 will be compared to the baseline and against any improvements in visual hallucinations. | — |
Countries
United Kingdom
Outcome results
None listed