tDCS+ cognitive training in neurocognitive disorders.

JRCT ID: jRCTs032180016

Registered date:29/08/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Major or minor Neurocognitive Disorders
• Date of first enrollment: 07/09/2018
• Target sample size: 92
• Study type: Interventional

Intervention(s)

Transcranial direct current stimulation
tDCS will be performed using a 1 by 1 low-intensity tDCS (Model 1300A; Soterix Medical Inc., New York, USA) that delivers direct current through two 35 cm2 electrodes. The anode electrode will be placed over the left dorsolateral prefrontal cortex, and the cathode will be placed over the contralateral supraorbital ridge using the 10/20 placement method. The participants in the active arm will receive active (2 mA) tDCS for 20 min per session, with two sessions per day or 5 consecutive days. Those in the sham arm will receive sham tDCS for the same number of sessions and days. All the participants will take part in cognitive training tasks during each 20-min stimulation session. These tasks will consist of a 20-min calculation tasks.

Outcome(s)

• Primary Outcome: between-group differences in mean ADAS-Cog from the baseline
• Secondary Outcome: between-group differences in mean RBANS, MMSE, GDS, SF-36 from the baseline

Key inclusion & exclusion criteria

• Age minimum: >= 55age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

(a) subjects aged 55-90 years, with a diagnosis of either major neurocognitive disorder or mild neurocognitive disorder, as defined in DSM-5
(b) subjects taking a stable dose of psychotropic medications, such as cholinesterase inhibitors or NMDA (N-Methyl-D-aspartic acid) receptor antagonists, for the preceding two weeks prior to enrollment, or who do not take any psychotropic medications, cholinesterase inhibitors, or NMDA receptor antagonists.
(c) subjects who are able to walk independently, with or without an aiding device
(d) Benzodiazepines were allowed but were tapered to a maximum dose of 20 mg per day of a diazepam equivalent; the dose remained stable during the trial.

Exclude criteria

(a) subjects with severe psychotic symptoms requiring antipsychotic treatment
(b) subjects requiring hospitalization within six weeks because of severe depression and/or suicidal ideation
(c) subjects who have a clinical contraindication to electroconvulsive therapy or tDCS
(d) subjects with an MMSE score of less than 18 or a Clinical Dementia Rating- Japan score of more than two
(e) subjects who are unable to participate for more than two days during the trial
(f) subjects who failed subsets (writing a sentence or copying a figure) in the MMSE at the time of screening.
(g) subjects who are thought of as not adequate for participation by principal investigator.

Related Information

• Primary Sponsor: Inagawa Takuma
• Source(s) of Monetary Support: Grants-in-Aid for scientific research