Effects of t-DCS and Cognitive Training on Apathy in Elderly With Minor Neurocognitive Impairment (FAME3)
Primary Purpose
Apathy, Neurocognitive Disorders
Status
Enrolling by invitation
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SHAM tDCS
tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Apathy
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 65 years
- Subject consulting in one of the investigating centers
- Clinical diagnosis of Minor Neurocognitive Disorder according to DSM 5 criteria (APA, 2013)
- Apathetic syndrome defined according to the Diagnostic Criteria for Apathy (Miller & al., 2021)
- Subject who can read and write French
- Subjects who are beneficiaries of a social security plan
- Signature of free and informed consent
Exclusion Criteria:
- Current clinical diagnosis of a depressive episode characterized by DSM 5 criteria (APA, 2013)
- Known diagnosis of schizophrenia, bipolar disorder, substance abuse or dependence
- Significant sensory or motor impairment
- Subject under guardianship, conservatorship, or conservatorship
- Active smoking or smoking cessation of less than one year
- Contraindications to the practice of tDCS: history of intracranial hypertension, neurosurgery, metallic implant at the cephalic level, pacemaker
- Unbalanced epilepsy
- Severe somatic disease not stabilized
- Previous use of tDCS (problem of maintaining the integrity of the blinding procedure)
- Scalp skin disease
- Concurrent participation in another drug research study or any other study that may interfere with study results
Sites / Locations
- Centre Memoire Ressources et Recherche, CHU de Nice
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
tDCS combined with simultaneous cognitive training
cognitive training with a combined sham tDCS
Arm Description
Outcomes
Primary Outcome Measures
Apathy Inventory (Robert et al., 2002), clinician version
The Apathy Inventory scored from 0 (No problem) to 4 (major problem) the 3 dimensions of apathy: the emotional blunting, the loss of initiative and the loss of interest. A higher total score indicates a greater severity.
Secondary Outcome Measures
Assessment of neuropsychiatric symptoms
Clinician assess behavioral symptoms and scored the severity from 0 to 3.
Assessment of the global cognitive functioning
Mini mental state examination (MMSE): test for asses the global cognitive functioning
Unit of measure: score
Scored from 0 to 30. A lower score indicate lower performance in global cognitive functioning.
Assessment of cognitive functions with FAB
Frontal assessment battery (FAB): test for asses global executive functions
Unit of measure: score
Scored from 0 to 18. A lower score indicate lower performance in global executive functions.
Assessment of episodic memory
Grober and Bruschke test : test for asses episodic memory
Unit of measure: score
Scored from 0 to 48. A lower score indicate lower performance in episodic memory
Assessment of attention and mental flexibilty
Trail Making test A_b: test for attention and mental flexibilty
Unit of measure: time to realize the test
A longer time indicate a lower performance in attention and mental flexibility.
Assessment of working memory
Empan de chiffres: test for asses working memory
Unit of measure: score
A lower score indicate a lower performance in working memory
Assessment of verbal fluency
Fluency test: test for asses verbal fluency
Unit of measure: number of words produced by the participant into 60 seconds
A lower score indicate a lower performance.
Assessment of language
Test de "dénomination d'image": test for asses language
Unit of measure: score
A lower score indicate a lower performance.
Assessment of fatigue with Multidimensional fatigue inventory (MFI)
Multidimensional fatigue inventory (MFI): 20-item self-report questionnaire for measuring five dimensions of fatigue.
Each subscale contains four items, which are scored on a five-point Likert-scale.
Scores range from 4 (absence of fatigue) to 20 (maximum fatigue) for each subscale.
Unit of measure: score
Assessment of fatigue with 15-sec Sustained maximal handgrip contraction
15-sec Sustained maximal handgrip contraction: The decrease in force during the 15-s was used as the indicator of fatigability.
Measure: performance for the test: The decrease in force during the 15-s was used as the indicator of fatigability. It was computed as the difference between the area under constant curve equal to the maximal grip force and the area under the force-time curve of 15-s
Assessment of daily physical activity
Actigraphy: assessment of time physical activity of light, moderate and vigorous intensity and sedentary time in daily life in minute and % of daily activity.
Assessment of tDCS adverse effects questionnaire
tDCS adverse effects questionnaire: questionnaire for asses the tDCS adverse effects.
It is a 11-item scale. Each item corresponds to an adverse effect. Each item is scored from 1 (absence of the adverse effect) to 4 (severe). If the adverse effect is present (score>1) the clinician scored if this is related to tdCS from 0 (none) to 5 (definite).
A higher score indicate more adverse effects.
Unit of measure: score
Full Information
NCT ID
NCT05232877
First Posted
December 21, 2021
Last Updated
October 6, 2022
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT05232877
Brief Title
Effects of t-DCS and Cognitive Training on Apathy in Elderly With Minor Neurocognitive Impairment
Acronym
FAME3
Official Title
Effects of t-DCS Combined With Concurrent Cognitive Training on Apathy in Elderly Subjects With Minor Neurocognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 5, 2022 (Actual)
Primary Completion Date
November 18, 2022 (Anticipated)
Study Completion Date
October 4, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique using a low intensity electric current to modify cortical excitability. Apathy is a pervasive neuropsychiatric symptom characterized by a reduction in goal-directed behavior and activity that persists over time and causes identifiable functional impairment. The aim of this study is to evaluate the effects of repeated sessions of tDCS combined with simultaneous cognitive training on apathy in older people with minor neurocognitive disorders.
Detailed Description
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique using a low intensity electric current to modify cortical excitability. There is growing interest for tDCS for psychiatric illnesses, notably for depression.
Apathy is a pervasive neuropsychiatric symptom characterized by a reduction in goal-directed behavior and activity that persists over time and causes identifiable functional impairment. tDCS could be a promising new area for non-pharmacological treatment of apathy.
The aim of this study is to evaluate the effects of repeated sessions of tDCS combined with simultaneous cognitive training on apathy in older people with minor neurocognitive disorders. For this, 30 apathetic subjects with minor neurocognitive disorders will be included and randomized between two groups. The intervention group will follow sessions of tDCS combined with a simultaneous cognitive training on tablet. The control group will follow cognitive training with a combined sham tDCS. Intervention will last for 4-week with 3 sessions per week (12 sessions). Stimulation will be performed with Startim 20 (Neuroelectrics®) which is approved by the European Union as a Class IIa medical device and meeting European safety standards. Stimulation will last for 20 minutes and the dorsolateral prefrontal cortex (F3) will be targeted. For the intervention group, the electric current will be 2mA. Assessments will be done at baseline, just after the end of intervention and 3 months after intervention. Apathy, daily functional motor behaviors, cognitive functions and fatigue will be assessed with clinician assessment, self-administered questionnaires, ambulatory actigraphy and cognitive tests. The assessments and the intervention will be done by different people. Study will be a double-blind randomized controlled trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apathy, Neurocognitive Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention group will follow sessions of tDCS combined with a simultaneous cognitive training on tablet.
he control group will follow cognitive training with a combined sham tDCS. Intervention will last for 4-week with 3 sessions per week (12 sessions).
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tDCS combined with simultaneous cognitive training
Arm Type
Experimental
Arm Title
cognitive training with a combined sham tDCS
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
SHAM tDCS
Intervention Description
The control group will follow cognitive training with a combined sham tDCS. Intervention will last for 4-week with 3 sessions per week (12 sessions).
Intervention Type
Other
Intervention Name(s)
tDCS
Intervention Description
The intervention group will follow sessions of tDCS combined with a simultaneous cognitive training on tablet
Primary Outcome Measure Information:
Title
Apathy Inventory (Robert et al., 2002), clinician version
Description
The Apathy Inventory scored from 0 (No problem) to 4 (major problem) the 3 dimensions of apathy: the emotional blunting, the loss of initiative and the loss of interest. A higher total score indicates a greater severity.
Time Frame
Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Secondary Outcome Measure Information:
Title
Assessment of neuropsychiatric symptoms
Description
Clinician assess behavioral symptoms and scored the severity from 0 to 3.
Time Frame
Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Title
Assessment of the global cognitive functioning
Description
Mini mental state examination (MMSE): test for asses the global cognitive functioning
Unit of measure: score
Scored from 0 to 30. A lower score indicate lower performance in global cognitive functioning.
Time Frame
Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Title
Assessment of cognitive functions with FAB
Description
Frontal assessment battery (FAB): test for asses global executive functions
Unit of measure: score
Scored from 0 to 18. A lower score indicate lower performance in global executive functions.
Time Frame
Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Title
Assessment of episodic memory
Description
Grober and Bruschke test : test for asses episodic memory
Unit of measure: score
Scored from 0 to 48. A lower score indicate lower performance in episodic memory
Time Frame
Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Title
Assessment of attention and mental flexibilty
Description
Trail Making test A_b: test for attention and mental flexibilty
Unit of measure: time to realize the test
A longer time indicate a lower performance in attention and mental flexibility.
Time Frame
Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Title
Assessment of working memory
Description
Empan de chiffres: test for asses working memory
Unit of measure: score
A lower score indicate a lower performance in working memory
Time Frame
Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Title
Assessment of verbal fluency
Description
Fluency test: test for asses verbal fluency
Unit of measure: number of words produced by the participant into 60 seconds
A lower score indicate a lower performance.
Time Frame
Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Title
Assessment of language
Description
Test de "dénomination d'image": test for asses language
Unit of measure: score
A lower score indicate a lower performance.
Time Frame
Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Title
Assessment of fatigue with Multidimensional fatigue inventory (MFI)
Description
Multidimensional fatigue inventory (MFI): 20-item self-report questionnaire for measuring five dimensions of fatigue.
Each subscale contains four items, which are scored on a five-point Likert-scale.
Scores range from 4 (absence of fatigue) to 20 (maximum fatigue) for each subscale.
Unit of measure: score
Time Frame
Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Title
Assessment of fatigue with 15-sec Sustained maximal handgrip contraction
Description
15-sec Sustained maximal handgrip contraction: The decrease in force during the 15-s was used as the indicator of fatigability.
Measure: performance for the test: The decrease in force during the 15-s was used as the indicator of fatigability. It was computed as the difference between the area under constant curve equal to the maximal grip force and the area under the force-time curve of 15-s
Time Frame
Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Title
Assessment of daily physical activity
Description
Actigraphy: assessment of time physical activity of light, moderate and vigorous intensity and sedentary time in daily life in minute and % of daily activity.
Time Frame
Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
Title
Assessment of tDCS adverse effects questionnaire
Description
tDCS adverse effects questionnaire: questionnaire for asses the tDCS adverse effects.
It is a 11-item scale. Each item corresponds to an adverse effect. Each item is scored from 1 (absence of the adverse effect) to 4 (severe). If the adverse effect is present (score>1) the clinician scored if this is related to tdCS from 0 (none) to 5 (definite).
A higher score indicate more adverse effects.
Unit of measure: score
Time Frame
Changes from baseline severity of apathy at 4 weeks and 18 weeks are assessed (12 weeks after the end of intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 65 years
Subject consulting in one of the investigating centers
Clinical diagnosis of Minor Neurocognitive Disorder according to DSM 5 criteria (APA, 2013)
Apathetic syndrome defined according to the Diagnostic Criteria for Apathy (Miller & al., 2021)
Subject who can read and write French
Subjects who are beneficiaries of a social security plan
Signature of free and informed consent
Exclusion Criteria:
Current clinical diagnosis of a depressive episode characterized by DSM 5 criteria (APA, 2013)
Known diagnosis of schizophrenia, bipolar disorder, substance abuse or dependence
Significant sensory or motor impairment
Subject under guardianship, conservatorship, or conservatorship
Active smoking or smoking cessation of less than one year
Contraindications to the practice of tDCS: history of intracranial hypertension, neurosurgery, metallic implant at the cephalic level, pacemaker
Unbalanced epilepsy
Severe somatic disease not stabilized
Previous use of tDCS (problem of maintaining the integrity of the blinding procedure)
Scalp skin disease
Concurrent participation in another drug research study or any other study that may interfere with study results
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric ETTORE, MD
Organizational Affiliation
Nice University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Memoire Ressources et Recherche, CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of t-DCS and Cognitive Training on Apathy in Elderly With Minor Neurocognitive Impairment
We'll reach out to this number within 24 hrs