Transcranial Direct Current Stimulation for Depression in... | NCT02351388

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

NCT02351388

Sponsor

National Center of Neurology and Psychiatry, Japan

Status

Terminated

Last Update Posted

Feb 26, 2020Actual

Enrollment

4Actual

Phase

Not Applicable

Conditions

Alzheimer Disease
Depression

Interventions

Transcranial Direct Current Stimulation
Sham Stimulation

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

failure to recruit enough number of participants

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Mar 15, 2018Actual

First Submitted Date

Jan 27, 2015

First Submission Date that Met QC Criteria

Jan 27, 2015

First Posted Date

Jan 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2020

Last Update Posted Date

Feb 26, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active stimulation	Active Comparator	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	Device: Transcranial Direct Current Stimulation
Sham stimulation	Sham Comparator	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	Other: Sham Stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcranial Direct Current Stimulation	Device		Active stimulation
Sham Stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Attrition rate due to any adverse event		three weeks

Secondary Outcomes

Measure	Description	Time Frame
Rate of adverse events related to tDCS procedure		three weeks
Geriatric Depression Scale	a subjective scale for depressive symptoms	one week, two weeks, three weeks, five weeks (followup)

Other Outcomes

Measure	Description	Time Frame
Clinical Dementia Rating	severity of dementia	baseline
Quality of Life - Alzheimer's Disease	a QoL scale	baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants who meets criteria of probable Alzheimer's disease defined by NINCDS-ADRDA research criteria.
Participants who meets criteria of depression in Alzheimers defined by NIMH criteria.
Participants who have been on fixed dose (including participants without any prescription) of antidepressants for at least two weeks on the screening visit.
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.
Ambulatory participants with or without any aiding device
Participants who have one caregiver, who must live with the patient at least ten hours a week and must report the patient's behavior.
A study partner who can report how the participant is doing is needed.
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

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

90 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D003295	Convulsive Therapy
D013000	Psychiatric Somatic Therapies

ID	Term
D000544	Alzheimer Disease
D003863	Depression
D001519	Behavior