Transcranial Direct Current Stimulation for Depression in Alzheimer's Disease Patient - Preliminary Research

Not Applicable

Terminated

• Conditions: Alzheimer Disease; Depression
• Interventions: Other: Sham Stimulation; Device: Transcranial Direct Current Stimulation

• Registration Number: NCT02351388
• Lead Sponsor: National Center of Neurology and Psychiatry, Japan

Brief Summary

This project will investigate the safety and efficacy of transcranial direct current stimulation (tDCS) in the treatment of depression among patients with Alzheimer's disease. The investigators aim to ameliorate depressive symptoms among patient with Alzheimer's disease, by anodal stimulation on left dorsolateral prefrontal cortex and cathodal suppression on right supraorbital area. Active stimulation will be compare to sham condition in 20 patients (10 in each groups).

Detailed Description

This project will investigate the safety and efficacy of transcranial direct current stimulation (tDCS) in the treatment of depression among patients with Alzheimer's disease. tDCS causes an excitatory effect on the anode side and suppressing effect on the cathode side through sculp with very week currents (2 mA in this project). The investigators aim to ameliorate depressive symptoms among patient with Alzheimer's disease, by anodal stimulation on left dorsolateral prefrontal cortex and cathodal suppression on right supraorbital area. Active stimulation will be compare to sham condition in 20 patients (10 in each groups) from outpatient clinic in National Center of Neurology and Psychiatry, Japan.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-01-27
• Study First Submitted QC: 2015-01-27
• Study First Posted: 2015-01-30
• Primary Completion: 2017-12-31
• Study Completion: 2018-03-15
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

1. Participants who meets criteria of probable Alzheimer's disease defined by NINCDS-ADRDA research criteria.
2. Participants who meets criteria of depression in Alzheimers defined by NIMH criteria.
3. Participants who have been on fixed dose (including participants without any prescription) of antidepressants for at least two weeks on the screening visit.
4. Participants who have been on fixed dose (including participants not prescribed) of antidementia drugs (donepezil, rivastigmine, galantamine, and memantine) for at least for weeks on the screening visit.
5. Ambulatory participants with or without any aiding device
6. Participants who have one caregiver, who must live with the patient at least ten hours a week and must report the patient's behavior.
7. A study partner who can report how the participant is doing is needed.
8. Eligible family member must sign and give consent on behalf of participants, whereas participants can give assent.

Exclusion Criteria

Following potential participants will be excluded

1. In case their cognitive deficits are better explained by another disease (e.g., cerebral infarction, Parkinson disease, multiple sclerosis, normotensive hydrocephalus).
2. In case they have history of epilepsy
3. In case they need treatment by antipsychotics due to significant psychotic symptoms
4. In case they have urgent risk of suicide or severe depression and any doctor require their hospitalization to psychiatric units.
5. In case they have history of ineffectiveness with electroconvulsive therapy (ECT) or transcranial direct current stimulation (tDCS)
6. In case ECT or tDCS is clinically contraindicated
7. In case they are taking benzodiazepines or antiepileptic drugs on the screening visit
8. In case they scored less than ten on Mini Mental State Exam (MMSE) or scored 3 or more on Clinical Dementia Rating (CDR)
9. In case his/her GDS score is lower than 6 at baseline
10. In case he/she is unable to agree video recording on evaluation interview

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham stimulation	Sham Stimulation	Duration: 30 minutes Intensity: 2 mA Placement: left dorsolateral prefrontal cortex and right supraorbital area Size of electrodes: 5 cm x 7 cm Frequency: 5 days a week for three weeks
Active stimulation	Transcranial Direct Current Stimulation	Duration: 30 minutes Intensity: 2 mA Placement: left dorsolateral prefrontal cortex and right supraorbital area Size of electrodes: 5 cm x 7 cm Frequency: 5 days a week for three weeks

Primary Outcome Measures

Name	Time	Method
Attrition rate due to any adverse event	three weeks

Secondary Outcome Measures

Name	Time	Method
Geriatric Depression Scale	one week, two weeks, three weeks, five weeks (followup)	a subjective scale for depressive symptoms
Clinical Global Impression of Improvement	one, two, three and five weeks (followup)	Clinician-rated impression of improvement
Cornell Scale for Depression in Dementia	two weeks, three weeks, five weeks (followup)	a objective scale for depressive symptoms
Neuropsychiatric Inventory	three weeks, five weeks (followup)	a objective scale for neuropsychiatric symptoms
Zarit Burden Interview	three weeks, five weeks (followup)	a subjective scale for caregivers' burden
Starkstein Apathy Scale	two, three and five weeks (followup)	a subjective scale for apathy
Rate of adverse events related to tDCS procedure	three weeks

Trial Locations

Locations (1)

National Center of Neurology and Psychiatry; 🇯🇵 Kodaira, Tokyo, Japan