Alzheimer DiseaseMemStim-homeNCT04783350
Home-based Brain Stimulation for Memory
A study testing Transcranial alternating current stimulation (tACS) in people with Alzheimer Disease and Memory Loss, run by Hebrew SeniorLife at 1 site in United States.
Trial summary
The proposed project aims to systematically examine the feasibility of remote, caregiver-led tACS for older adults who are vulnerable to memory decline. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Memory Loss
- What is being tested?
- Transcranial alternating current stimulation (tACS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2020to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants (Ps)
- willing and capable to give informed consent for the participation in the study after it has been thoroughly explained
- able and willing to comply with all study requirements
- an informed consent form was signed
- able to read, write, and communicate in English
- able to identify an eligible administrator to participate with them in the study
Show all 11Show fewer
- Administrators (As)
- at least 21 years of age
- able to read, write, and communicate in English
- self-reported computer proficiency and willingness to learn how to use tACS as defined by "yes" answers to the questions "Do you feel comfortable using a computer?" and "Are you willing to be the primary caregiver for a participant and learn how to administer tACS?"
- stated availability during weekdays throughout the study period to administer tACS to the Ps
Who cannot join
- Participants (Ps)
- major psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis
- blindness or other disabilities that prevent task performance
- contraindications to tACS, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuroactive drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.)
- the presence of any active dermatological condition, such as eczema, on the scalp a score of 18 or less on the Montreal Cognitive Assessment (MoCA) during the in-person screen
- an inability to understand study procedures following review of the Informed Consent form
Show all 12Show fewer
- Understanding will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form (see attached). Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator
- Administrators (As)
- mild cognitive impairment defined by a MoCA score ≤26 during the in-person screen
- insufficient understanding of study procedures following review of the Informed Consent form
- Understanding will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form (see attached). Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.
- poor eyesight, severe arthritis in the hands, pain, deformity or other condition that interferes with successful administration of tACS
Trial locations and contacts
1 site in 1 country.
United States1 site
Hinda and Arthur Marcus Institute for Aging Research
Boston, Massachusetts, 02131
About this study
Official title: Home-based Transcranial Alternating Current Stimulation (tACS) for Older Adults at Risk of Memory Decline
The proposed project aims to systematically examine the feasibility of remote, caregiver-led tACS for older adults who are vulnerable to memory decline.
Read the detailed description
This is a feasibility study, which will include older adult participants (Ps) with memory deficits together with willing and able administrators (As) to administer tACS to the participants. This study will include 20 older Ps and 20 As to assess the feasibility of deploying home-based tACS in larger clinical trials, and to prepare for the development and implementation of such trials. The proposed project will systematically examine the feasibility of remote, caregiver-led tACS for older adults who are vulnerable to memory decline. This study will provide data to support the safety and effectiveness of home-based tACS in this population and will lead to future research to increase access of tACS as a part of memory decline prevention and treatment for older adults who have more difficulty reaching a clinic for treatment due to disability or who live more remotely.
- Conditions
- Alzheimer Disease, Memory Loss
- Being tested
- Transcranial alternating current stimulation (tACS)
- Keywords
- alzheimer disease, memory and cognition, autobiographical memory, transcranial alternating current stimulation (tACS), guided high-density electroencephalography (hdEEG)
- Medical subject headings
- Alzheimer Disease, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial alternating current stimulation (tACS)Device
Also called non-invasive brain stimulation
tACS will be administered to the left angular gyrus at gamma frequency to improve cognitive functioning (MoCA score) and resting-state EEG signatures.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial alternating current stimulation (tACS) | Experimental | Participants (Ps) will undergo 20min of daily home-based tACS intervention at 40Hz over the left angular gyrus for 4 weeks by trained administrators (As) (phase 1). In case of cognitive and mental improvement participants will undergo further 10 weeks of 20 minutes session of tACS daily (phase 2). Additionally, those P/A pairs who completed the 14 weeks of home-based tACS intervention and express an interest in an open label extension may be enrolled in further 34 weeks of 20 minutes tACS sessions. Receives: Device: Transcranial alternating current stimulation (tACS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Evaluation and Cognitive Assessment
a trained clinician will administer the Montreal Cognitive Assessment (MOCA) to characterize cognitive status and the level of dementia
Measured: 48 weeks
Electroencephalography (EEG) measures
High-density EEG (257 channels) will be recorded before and after the tACS intervention and changes in spatiotemporal dynamics in different frequency bands (theta, alpha, beta, gamma) will be assessed
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start6 Jul 2020
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alvaro Pascual-Leone, Hebrew SeniorLife
- Investigators
- Alvaro Pascual-Leone, Dr., Principal investigator, Hinda and Arthur Marcus Institute for Aging Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783350
- Sponsor's protocol ID
- Pro00044646
- Acronym
- MemStim-home
- Status last verified
- Jun 2024
- First submitted
- 26 Feb 2021
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Struber D, Herrmann CS. Modulation of gamma oscillations as a possible therapeutic tool for neuropsychiatric diseases: A review and perspective. Int J Psychophysiol. 2020 Jun;152:15-25. doi: 10.1016/j.ijpsycho.2020.03.003. Epub 2020 Mar 30.
PubMed 32240665Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19.
PubMed 28709880Babiloni C, Blinowska K, Bonanni L, Cichocki A, De Haan W, Del Percio C, Dubois B, Escudero J, Fernandez A, Frisoni G, Guntekin B, Hajos M, Hampel H, Ifeachor E, Kilborn K, Kumar S, Johnsen K, Johannsson M, Jeong J, LeBeau F, Lizio R, Lopes da Silva F, Maestu F, McGeown WJ, McKeith I, Moretti DV, Nobili F, Olichney J, Onofrj M, Palop JJ, Rowan M, Stocchi F, Struzik ZM, Tanila H, Teipel S, Taylor JP, Weiergraber M, Yener G, Young-Pearse T, Drinkenburg WH, Randall F. What electrophysiology tells us about Alzheimer's disease: a window into the synchronization and connectivity of brain neurons. Neurobiol Aging. 2020 Jan;85:58-73. doi: 10.1016/j.neurobiolaging.2019.09.008. Epub 2019 Sep 19.
PubMed 31739167Buss SS, Fried PJ, Pascual-Leone A. Therapeutic noninvasive brain stimulation in Alzheimer's disease and related dementias. Curr Opin Neurol. 2019 Apr;32(2):292-304. doi: 10.1097/WCO.0000000000000669.
PubMed 30720478Ruffini G, Fox MD, Ripolles O, Miranda PC, Pascual-Leone A. Optimization of multifocal transcranial current stimulation for weighted cortical pattern targeting from realistic modeling of electric fields. Neuroimage. 2014 Apr 1;89:216-25. doi: 10.1016/j.neuroimage.2013.12.002. Epub 2013 Dec 15.
PubMed 24345389Brechet L, Brunet D, Birot G, Gruetter R, Michel CM, Jorge J. Capturing the spatiotemporal dynamics of self-generated, task-initiated thoughts with EEG and fMRI. Neuroimage. 2019 Jul 1;194:82-92. doi: 10.1016/j.neuroimage.2019.03.029. Epub 2019 Mar 19.
PubMed 30902640Cappon D, Fox R, den Boer T, Yu W, LaGanke N, Cattaneo G, Perellon-Alfonso R, Bartres-Faz D, Manor B, Pascual-Leone A. Tele-supervised home-based transcranial alternating current stimulation (tACS) for Alzheimer's disease: a pilot study. Front Hum Neurosci. 2023 Jun 2;17:1168673. doi: 10.3389/fnhum.2023.1168673. eCollection 2023.
PubMed 37333833
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Transcranial Alternating Current Stimulation (tACS) for Older Adults at Risk of Memory Decline
- ClinicalTrials.gov ID
- NCT04783350
- Acronym / sponsor ID
- MemStim-home / Pro00044646
- Conditions
- Alzheimer Disease, Memory Loss
- Keywords
- alzheimer disease, memory and cognition, autobiographical memory, transcranial alternating current stimulation (tACS), guided high-density electroencephalography (hdEEG)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed project aims to systematically examine the feasibility of remote, caregiver-led tACS for older adults who are vulnerable to memory decline.
Detailed description
This is a feasibility study, which will include older adult participants (Ps) with memory deficits together with willing and able administrators (As) to administer tACS to the participants. This study will include 20 older Ps and 20 As to assess the feasibility of deploying home-based tACS in larger clinical trials, and to prepare for the development and implementation of such trials. The proposed project will systematically examine the feasibility of remote, caregiver-led tACS for older adults who are vulnerable to memory decline. This study will provide data to support the safety and effectiveness of home-based tACS in this population and will lead to future research to increase access of tACS as a part of memory decline prevention and treatment for older adults who have more difficulty reaching a clinic for treatment due to disability or who live more remotely.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial alternating current stimulation (tACS) | Experimental | Device: Transcranial alternating current stimulation (tACS)Participants (Ps) will undergo 20min of daily home-based tACS intervention at 40Hz over the left angular gyrus for 4 weeks by trained administrators (As) (phase 1). In case of cognitive and mental improvement participants will undergo further 10 weeks of 20 minutes session of tACS daily (phase 2). Additionally, those P/A pairs who completed the 14 weeks of home-based tACS intervention and express an interest in an open label extension may be enrolled in further 34 weeks of 20 minutes tACS sessions. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants (Ps)
- willing and capable to give informed consent for the participation in the study after it has been thoroughly explained
- able and willing to comply with all study requirements
- an informed consent form was signed
- able to read, write, and communicate in English
Key exclusion criteria (12 listed)
- Participants (Ps)
- major psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis
- blindness or other disabilities that prevent task performance
- contraindications to tACS, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuroactive drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.)
- the presence of any active dermatological condition, such as eczema, on the scalp a score of 18 or less on the Montreal Cognitive Assessment (MoCA) during the in-person screen
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 |
|---|---|---|
| Transcranial alternating current stimulation (tACS)Also: non-invasive brain stimulationtACS will be administered to the left angular gyrus at gamma frequency to improve cognitive functioning (MoCA score) and resting-state EEG signatures. | Device | Transcranial alternating current stimulation (tACS) |
Primary outcome
Clinical Evaluation and Cognitive Assessment
Time frame: 48 weeks
a trained clinician will administer the Montreal Cognitive Assessment (MOCA) to characterize cognitive status and the level of dementia
Electroencephalography (EEG) measures
Time frame: 48 weeks
High-density EEG (257 channels) will be recorded before and after the tACS intervention and changes in spatiotemporal dynamics in different frequency bands (theta, alpha, beta, gamma) will be assessed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Background: PubMed 32240665Struber D, Herrmann CS. Modulation of gamma oscillations as a possible therapeutic tool for neuropsychiatric diseases: A review and perspective. Int J Psychophysiol. 2020 Jun;152:15-25. doi: 10.1016/j.ijpsycho.2020.03.003. Epub 2020 Mar 30.
- Results publication: PubMed 28709880Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19.
- Results publication: PubMed 31739167Babiloni C, Blinowska K, Bonanni L, Cichocki A, De Haan W, Del Percio C, Dubois B, Escudero J, Fernandez A, Frisoni G, Guntekin B, Hajos M, Hampel H, Ifeachor E, Kilborn K, Kumar S, Johnsen K, Johannsson M, Jeong J, LeBeau F, Lizio R, Lopes da Silva F, Maestu F, McGeown WJ, McKeith I, Moretti DV, Nobili F, Olichney J, Onofrj M, Palop JJ, Rowan M, Stocchi F, Struzik ZM, Tanila H, Teipel S, Taylor JP, Weiergraber M, Yener G, Young-Pearse T, Drinkenburg WH, Randall F. What electrophysiology tells us about Alzheimer's disease: a window into the synchronization and connectivity of brain neurons. Neurobiol Aging. 2020 Jan;85:58-73. doi: 10.1016/j.neurobiolaging.2019.09.008. Epub 2019 Sep 19.
- Results publication: PubMed 30720478Buss SS, Fried PJ, Pascual-Leone A. Therapeutic noninvasive brain stimulation in Alzheimer's disease and related dementias. Curr Opin Neurol. 2019 Apr;32(2):292-304. doi: 10.1097/WCO.0000000000000669.
- Results publication: PubMed 24345389Ruffini G, Fox MD, Ripolles O, Miranda PC, Pascual-Leone A. Optimization of multifocal transcranial current stimulation for weighted cortical pattern targeting from realistic modeling of electric fields. Neuroimage. 2014 Apr 1;89:216-25. doi: 10.1016/j.neuroimage.2013.12.002. Epub 2013 Dec 15.
- Results publication: PubMed 30902640Brechet L, Brunet D, Birot G, Gruetter R, Michel CM, Jorge J. Capturing the spatiotemporal dynamics of self-generated, task-initiated thoughts with EEG and fMRI. Neuroimage. 2019 Jul 1;194:82-92. doi: 10.1016/j.neuroimage.2019.03.029. Epub 2019 Mar 19.
- Derived from this study: PubMed 37333833Cappon D, Fox R, den Boer T, Yu W, LaGanke N, Cattaneo G, Perellon-Alfonso R, Bartres-Faz D, Manor B, Pascual-Leone A. Tele-supervised home-based transcranial alternating current stimulation (tACS) for Alzheimer's disease: a pilot study. Front Hum Neurosci. 2023 Jun 2;17:1168673. doi: 10.3389/fnhum.2023.1168673. eCollection 2023.
- 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.
Alvaro Pascual-Leone, Dr. principal investigator
Hinda and Arthur Marcus Institute for Aging Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial alternating current stimulation (tACS) in people with Alzheimer Disease and Memory Loss, run by Hebrew SeniorLife 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 11 inclusion and 12 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 25 Jun 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical Evaluation and Cognitive Assessment (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04783350, which also lists 7 linked publications.
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 25 Jun 2024.