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

NCT ID: NCT02351388

Last Updated: 2020-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2018-03-15

Brief Summary

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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

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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.

Conditions

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Alzheimer Disease Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active 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

Group Type ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type DEVICE

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

Group Type SHAM_COMPARATOR

Sham Stimulation

Intervention Type OTHER

Interventions

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Transcranial Direct Current Stimulation

Intervention Type DEVICE

Sham Stimulation

Intervention Type OTHER

Eligibility Criteria

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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

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
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center of Neurology and Psychiatry, Japan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuma Yokoi, MD

Role: PRINCIPAL_INVESTIGATOR

National Center of Neurology and Psychiatry, Japan

Locations

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National Center of Neurology and Psychiatry

Kodaira, Tokyo, Japan

Site Status

Countries

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Japan

References

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Narita Z, Yokoi Y. Transcranial direct current stimulation for depression in Alzheimer's disease: study protocol for a randomized controlled trial. Trials. 2017 Jun 19;18(1):285. doi: 10.1186/s13063-017-2019-z.

Reference Type DERIVED
PMID: 28629447 (View on PubMed)

Related Links

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Other Identifiers

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A2014-086

Identifier Type: -

Identifier Source: org_study_id

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