Alzheimer's Disease and Related DementiasNCT04457973
Home-based Transcranial Direct Current Stimulation for Pain Management in Persons With Alzheimer's Disease and Related Dementias
A study testing Active tDCS in people with Alzheimer's Disease and Related Dementias, run by Florida State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer's Disease and Related Dementias
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2020to 19 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Home-based Transcranial Direct Current Stimulation (tDCS) for Pain Management in Persons With Alzheimer's Disease and Related Dementias
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.
- Being tested
- Active tDCS, Sham tDCS
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
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.
Sham tDCSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Not described Receives: Device: Active tDCS |
| Sham tDCS | Placebo comparator | Not described Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline (day 1), end of intervention (day 5)
Secondary outcomes (6)
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.
Measured: baseline (day 1), end of intervention (day 5)
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.
Measured: baseline (day 1), end of intervention (day 5)
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.
Measured: baseline (day 1), end of intervention (day 5)
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.
Measured: baseline (day 1), end of intervention (day 5)
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.
Measured: end of intervention (day 5)
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.
Measured: end of intervention (day 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start4 Sep 2020
- Primary completion19 Oct 2022
- Study completion19 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's Disease and Related DementiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Hyochol Ahn, PhD, Florida State University
- Investigators
- Hyochol Ahn, RN,PhD,MSN, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457973
- Sponsor's protocol ID
- HSC-SN-20-0640
- Other IDs
- R15NR018050
- Status last verified
- Sep 2023
- First submitted
- 1 Jul 2020
- Last updated
- 13 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Transcranial Direct Current Stimulation (tDCS) for Pain Management in Persons With Alzheimer's Disease and Related Dementias
- ClinicalTrials.gov ID
- NCT04457973
- Acronym / sponsor ID
- HSC-SN-20-0640
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 19 Oct 2022 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Posted 13 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Active tDCS |
| Sham tDCS | Placebo comparator | Device: Sham tDCS |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCStDCS 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. | Device | Active tDCS |
| Sham tDCSThe electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds. | Device | Sham tDCS |
Primary outcome
Pain as Assessed by the Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) Scale
Time frame: 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.
6 secondary outcomes
Clinical Pain as Assessed by a Numerical Rating Scale (NRS)
Time frame: baseline (day 1), end of intervention (day 5)
Behavioral and Psychological Symptoms of Dementia (BPSD) as Measured by the Cohen-Mansfield Agitation Inventory (CMAI)
Time frame: baseline (day 1), end of intervention (day 5)
Behavioral and Psychological Symptoms as Assessed by Neuropsychiatric Inventory (NPI)
Time frame: baseline (day 1), end of intervention (day 5)
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
Time frame: baseline (day 1), end of intervention (day 5)
Acceptability as Measured by the tDCs Experience Questionnaire
Time frame: end of intervention (day 5)
Patient Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ)
Time frame: end of intervention (day 5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyochol Ahn, RN,PhD,MSN principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS in people with Alzheimer's Disease and Related Dementias, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain as Assessed by the Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) Scale (time frame: baseline (day 1), end of intervention (day 5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.