Alzheimer's Disease and Related Dementias
Conditions
Brief summary
The purpose of this project is to evaluate the preliminary effects of home-based M1-SO applied tDCS (that is, tDCS with the anode over the primary motor cortex and the cathode over the contralateral supraorbital area) on clinical pain in persons with early-stage Alzheimer's disease and Related Dementias (ADRD), to evaluate the preliminary effects of home-based M1-SO applied tDCS on pain-related cortical response in persons with early-stage ADRD, and to evaluate the feasibility and acceptability of home-based M1-SO applied tDCS for pain management in persons with early-stage AD.
Interventions
DEVICEActive tDCS
tDCS with a constant current intensity of 2 milliampere (mA) will be applied for 20 minutes per session daily for 5 days via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and 5x7 cm saline-soaked surface sponge electrodes.
DEVICESham tDCS
The electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds.
Sponsors
National Institute of Nursing Research (NINR)
Florida State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* early-stage Alzhimer's disease and related dementias (ADRD) * have caregiver-reported chronic pain (average pain in the past 3 months ≥ 3 out of 10), * have a caregiver willing to participate in the study who sees the participant at least 10 hours/week * can speak and read English * have no plans to change medication regimens during the trial
Exclusion criteria
* history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation * alcohol/substance abuse * severely diminished cognitive function (i.e., MiniMental Status Exam score ≤ 15) * hospitalization within the preceding year for neuropsychiatric illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain as Assessed by the Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) Scale | baseline (day 1), end of intervention (day 5) | Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) is a 10 question scale, each question rated from 0-10. The total score ranges between 0-100 with a higher number indicating a worse outcome. The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Behavioral and Psychological Symptoms of Dementia (BPSD) as Measured by the Cohen-Mansfield Agitation Inventory (CMAI) | baseline (day 1), end of intervention (day 5) | Cohen-Mansfield Agitation Inventory (CMAI) is a 29 question scale, each question measured from 1-7. Total score ranges from 29-203 with a higher score indicating a worse outcome. The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported. |
| Behavioral and Psychological Symptoms as Assessed by Neuropsychiatric Inventory (NPI) | baseline (day 1), end of intervention (day 5) | Neuropsychiatric Inventory (NPI) total score ranges from 0-144, with a higher score indicating greater symptoms. The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported. |
| Clinical Pain as Assessed by a Numerical Rating Scale (NRS) | baseline (day 1), end of intervention (day 5) | Numeric Rating Scale (NRS) total score ranges from 0 (no pain) to 100 (most intense pain imaginable). The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported. |
| Acceptability as Measured by the tDCs Experience Questionnaire | end of intervention (day 5) | The tDCS experience questionnaire contains 10 questions based on a scale from 0-10, 0 being strongly disagree and 10 being strongly agree. Higher scores indicating greater acceptability for 7 questions and lower scores indicating greater acceptability for 3 reversed questions. Total score ranges from 0-100 with a most desirable score of a 70. |
| Patient Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ) | end of intervention (day 5) | Client Satisfaction Questionnaire (CSQ) consists of 8 questions, each is rated between 1-4. The total score ranges from 8-32 with a higher score indicating a higher satisfaction. |
| Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System | baseline (day 1), end of intervention (day 5) | Pain-related cortical response will be measured during thermal pain stimulation using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) composed of 8 source and 8 detector channels. fNIRS signals between each source-to-detector pair are analyzed using a general linear model, Y = X\*Beta + E , to test for statistical differences between the baseline (day 1) and the end of intervention (day 5). Y is the measured fNIRS signal, X is an array encoding the expected/hypothetical response, E is an error term, and Beta is interpreted as the strength/amplitude of the functional activation. Greater absolute Beta values denote that the change in cortical response between two sessions is greater. The calculated Beta values are expressed in arbitrary units. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active tDCS 2mA current is applied for 20 minutes. | 20 |
| Sham tDCS 2mA current is applied for 30 seconds. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Sham tDCS | Total | Active tDCS |
|---|---|---|---|
| Age, Continuous | 71.90 years STANDARD_DEVIATION 8.97 | 73 years STANDARD_DEVIATION 7.83 | 74.10 years STANDARD_DEVIATION 6.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 39 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 37 Participants | 18 Participants |
| Sex: Female, Male Female | 15 Participants | 28 Participants | 13 Participants |
| Sex: Female, Male Male | 5 Participants | 12 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Pain as Assessed by the Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) Scale
Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) is a 10 question scale, each question rated from 0-10. The total score ranges between 0-100 with a higher number indicating a worse outcome. The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported.
Time frame: baseline (day 1), end of intervention (day 5)
Population: Comparison of pain intensity changes between two groups at 5 days from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS | Pain as Assessed by the Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) Scale | -2.70 score on a scale | Standard Deviation 2.39 |
| Sham tDCS | Pain as Assessed by the Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) Scale | -.40 score on a scale | Standard Deviation 1.67 |
Secondary
Acceptability as Measured by the tDCs Experience Questionnaire
The tDCS experience questionnaire contains 10 questions based on a scale from 0-10, 0 being strongly disagree and 10 being strongly agree. Higher scores indicating greater acceptability for 7 questions and lower scores indicating greater acceptability for 3 reversed questions. Total score ranges from 0-100 with a most desirable score of a 70.
Time frame: end of intervention (day 5)
Population: Comparison of total score of tDCS experience questionnaire between two groups at 5 days from baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS | Acceptability as Measured by the tDCs Experience Questionnaire | 62.05 score on a scale | Standard Deviation 8.76 |
| Sham tDCS | Acceptability as Measured by the tDCs Experience Questionnaire | 67.95 score on a scale | Standard Deviation 11.06 |
Secondary
Behavioral and Psychological Symptoms as Assessed by Neuropsychiatric Inventory (NPI)
Neuropsychiatric Inventory (NPI) total score ranges from 0-144, with a higher score indicating greater symptoms. The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported.
Time frame: baseline (day 1), end of intervention (day 5)
Population: Comparison of NPI score changes between two groups at 5 days from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS | Behavioral and Psychological Symptoms as Assessed by Neuropsychiatric Inventory (NPI) | -2.9 score on a scale | Standard Deviation 15.08 |
| Sham tDCS | Behavioral and Psychological Symptoms as Assessed by Neuropsychiatric Inventory (NPI) | -2.30 score on a scale | Standard Deviation 11.59 |
Secondary
Behavioral and Psychological Symptoms of Dementia (BPSD) as Measured by the Cohen-Mansfield Agitation Inventory (CMAI)
Cohen-Mansfield Agitation Inventory (CMAI) is a 29 question scale, each question measured from 1-7. Total score ranges from 29-203 with a higher score indicating a worse outcome. The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported.
Time frame: baseline (day 1), end of intervention (day 5)
Population: Comparison of CMAI score changes between two groups at 5 days from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS | Behavioral and Psychological Symptoms of Dementia (BPSD) as Measured by the Cohen-Mansfield Agitation Inventory (CMAI) | -2.35 score on a scale | Standard Deviation 5.99 |
| Sham tDCS | Behavioral and Psychological Symptoms of Dementia (BPSD) as Measured by the Cohen-Mansfield Agitation Inventory (CMAI) | -2.95 score on a scale | Standard Deviation 5.24 |
Secondary
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
Pain-related cortical response will be measured during thermal pain stimulation using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) composed of 8 source and 8 detector channels. fNIRS signals between each source-to-detector pair are analyzed using a general linear model, Y = X\*Beta + E , to test for statistical differences between the baseline (day 1) and the end of intervention (day 5). Y is the measured fNIRS signal, X is an array encoding the expected/hypothetical response, E is an error term, and Beta is interpreted as the strength/amplitude of the functional activation. Greater absolute Beta values denote that the change in cortical response between two sessions is greater. The calculated Beta values are expressed in arbitrary units.
Time frame: baseline (day 1), end of intervention (day 5)
Population: Comparison of Beta value changes between two groups at 5 days from baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active tDCS | Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System | source 1, detector 1 | -6.39 Beta value |
| Active tDCS | Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System | source 2, detector 2 | 2.31 Beta value |
| Active tDCS | Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System | source 3, detector 3 | -3.60 Beta value |
| Active tDCS | Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System | source 4, detector 4 | -8.35 Beta value |
| Active tDCS | Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System | source 5, detector 5 | -1.03 Beta value |
| Active tDCS | Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System | source 6, detector 6 | -1.99 Beta value |
| Active tDCS | Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System | source 7, detector 7 | -1.61 Beta value |
| Active tDCS | Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System | source 8, detector 8 | 3.88 Beta value |
| Sham tDCS | Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System | source 8, detector 8 | 8.33 Beta value |
| Sham tDCS | Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System | source 1, detector 1 | -5.30 Beta value |
| Sham tDCS | Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System | source 5, detector 5 | -1.54 Beta value |
| Sham tDCS | Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System | source 2, detector 2 | -4.64 Beta value |
| Sham tDCS | Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System | source 7, detector 7 | -0.97 Beta value |
| Sham tDCS | Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System | source 3, detector 3 | 3.13 Beta value |
| Sham tDCS | Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System | source 6, detector 6 | -3.49 Beta value |
| Sham tDCS | Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System | source 4, detector 4 | -3.46 Beta value |
Secondary
Clinical Pain as Assessed by a Numerical Rating Scale (NRS)
Numeric Rating Scale (NRS) total score ranges from 0 (no pain) to 100 (most intense pain imaginable). The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported.
Time frame: baseline (day 1), end of intervention (day 5)
Population: Comparison of pain intensity changes between two groups at 5 days from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS | Clinical Pain as Assessed by a Numerical Rating Scale (NRS) | -13.55 score on a scale | Standard Deviation 14.9 |
| Sham tDCS | Clinical Pain as Assessed by a Numerical Rating Scale (NRS) | -3.30 score on a scale | Standard Deviation 14.81 |
Secondary
Patient Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ)
Client Satisfaction Questionnaire (CSQ) consists of 8 questions, each is rated between 1-4. The total score ranges from 8-32 with a higher score indicating a higher satisfaction.
Time frame: end of intervention (day 5)
Population: Comparison of total score of CSQ between two groups at 5 days from baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS | Patient Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ) | 28.75 score on a scale | Standard Deviation 2.92 |
| Sham tDCS | Patient Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ) | 28.55 score on a scale | Standard Deviation 3.14 |