Age-associated Memory ImpairmentNCT05462782
TMS for Investigating Memory Facilitation
A study testing Transcranial Magnetic Stimulation (TMS) Cone Coil in people with Age-associated Memory Impairment, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The aim of this study is to investigate the effects of Transcranial Magnetic Stimulation (TMS) following a Paired Associative Stimulation (PAS) protocol on the memorization capacity of elderly individuals. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-associated Memory Impairment
- What is being tested?
- Transcranial Magnetic Stimulation (TMS) Cone Coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2022to 3 Apr 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age from 60 to 85 years, inclusive (For piloting purposes, this inclusion criteria may vary).
- No history of a brain and/or skull lesion (e.g., stroke)
- Normal vision (can be corrected)
- Able to understand and give informed consent
- No neurological disorders
- Able to understand and speak English
Who cannot join
- Cardiac pacemaker or pacemaker wires; neurostimulators; implanted pumps
- Metal in the body (rods, plates, screws, shrapnel, dentures, IUD) or metallic particles in the eye
- Surgical clips in the head or previous neurosurgery
- Any magnetic particles in the body
- Cochlear implants
- Prosthetic heart valves
Show all 20Show fewer
- Epilepsy or any other type of seizure history
- History of significant head trauma (i.e., extended loss of consciousness, neurological sequelae)
- Significant claustrophobia
- Ménière's disease
- Pregnancy or breast feeding
- Non prescribed drug use
- History of current substance abuse (exception: current nicotine use is allowed)
- Marijuana
- Any neurological diagnoses
- Dementia; severe depression; or prior neurosurgical procedures
- Tremor or parkinsonism, or psychiatric disease that would interfere with study procedures for TMS, or MRI.
- Significant other disease (cardiological or heart disease, renal, hepatic, malignant tumors, mental or psychiatric disorders) that would prevent participants from fully engaging in study procedures
- Prisoners
- Medications contraindicated for TMS: antipsychotic and antidepressant medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Task Paired Transcranial Magnetic Stimulation for Working Memory Potentiation
The aim of this study is to investigate the effects of Transcranial Magnetic Stimulation (TMS) following a Paired Associative Stimulation (PAS) protocol on the memorization capacity of elderly individuals. For this purpose, we will apply TMS synchronized with a working memory (WM) task and assess its effects on cortical connectivity and memorization capacity by Magnetic Resonance Imaging (MRI) and WM task learning. This study will be carried out in an older population of healthy participants. We will use the study results to refine the task related PAS protocol towards enhancing memory performance and brain connectivity.
Read the detailed description
The fundamental objective is to evaluate the changes derived from the specific Paired Associative Stimulation (PAS) protocol applying Transcranial Magnetic Stimulation (TMS) towards the hippocampus to enhance memory in an older population. We will evaluate the following effects: 1) Changes in memory capacity using task performance of the working memory (WM) task and calculating the correctly memorized items; and 2) Changes in brain connectivity using resting state functional Magnetic Resonance Imaging (rs-fMRI) and comparing the correlated activity between areas related to the process of memorization.
In order to understand the memory and brain connectivity changes derived from the PAS intervention more specifically, we will characterize the stimulation localization, the Inter Stimulus Interval (ISI) timing and rule out training and placebo effects. To research if the PAS effects are specific to the stimulated brain area, we will conduct a control group in which stimulation will be delivered to the primary motor area (M1). Then, we will compare the outcome measures (changes in memory capacity and brain connectivity) between the different brain areas. To characterize the ISI, our goal is to calculate the synchronization timing that triggers cortical plastic changes. Thus, we will test two different ISI between the TMS pulse delivery and memorization task. Finally, to differentiate the effects that are derived from the PAS versus the effects from repetition of the task or placebo effects, we will conduct another control group with Sham TMS stimulation and reproduce the same experimental procedures as the group that receives the TMS stimulation. Sham TMS is used in this study to compare if brain stimulation (active TMS) can help improve memory compared to receiving no brain stimulation (sham TMS).
- Conditions
- Age-associated Memory Impairment
- Being tested
- Transcranial Magnetic Stimulation (TMS) Cone Coil, Transcranial Magnetic Stimulation (TMS) Sham Coil
- Keywords
- Transcranial Magnetic Stimulation, Paired Associative Stimulation, Working Memory, Older adults, Functional Magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS) Cone CoilDevice
The cone coil Cool-DB80 (MagPro, MagVenture, Alpharetta GA, US) will be used with an MRI-based TMS navigation system (Localite, St Augustin, Germany). TMS interventions will involve the following parameters: 1. Hippocampal directed stimulation at ISI 0ms, 2. Hippocampal directed stimulation at ISI 200ms, 3. Motor cortex stimulation at ISI 0ms, and 4. Motor cortex stimulation at ISI 200ms.
Transcranial Magnetic Stimulation (TMS) Sham CoilDevice
The sham coil Cool B65 A/P (MagPro, MagVenture, Alpharetta GA, US) will be used with an MRI-based TMS navigation system (Localite, St Augustin, Germany). The different TMS interventions will be involve the following parameters: 1. Sham stimulation at ISI 0ms, and 2. Sham stimulation at ISI 200ms.
| Study group | Role | What they receive |
|---|---|---|
| Active TMS | Experimental | Older healthy participants will be scanned with MRI and undergo memory task synchronized PAS with an active TMS in each visit with different stimulation localization and ISIs. Receives: Device: Transcranial Magnetic Stimulation (TMS) Cone Coil |
| Sham TMS | Sham comparator | Older healthy participants will be scanned with MRI and undergo memory task synchronized PAS with a sham TMS coil in each visit with different ISIs application. Receives: Device: Transcranial Magnetic Stimulation (TMS) Sham Coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Working Memory (WM) capacity
The WM task utilized is a customized version of the masking task model, presented by Sana Inoue and Tetsuro Matsuzawa, in 2007. This task is organized in three phases: 1) Waiting phase: a visual cue is presented to indicate the initiation of the trial; 2) Coding and retention phase: numbers are presented in a random arrangement within a 5x5 square matrix; and 3) Recall phase: the numbers disappear, leaving a white background as a clue, and the subject completes the task by pressing the squares in the matrix following the incremental order of the numbers. (Figure 2). The task ends either when the subject makes a mistake or completes correctly selecting all numbers in incremental order. The outcome measure for WM capacity is the amount of correctly remembered items (hit items) of each trial.
Measured: Compared during each visit between baseline, immediately after the intervention, and 30 minutes after intervention
Changes in resting state functional MRI connectivity
The neural connectivity index that we will assess responds to the strength of synaptic connections between neurons and over time. The identification of correlations between remote brain areas will be tested by resting state functional magnetic resonance imaging (rs-fMRI). We will compare the connectivity network after intervention time with baseline and sham group. Correlations of spontaneous modulations in the blood oxygen level dependent (BOLD) signal will be analyzed and regions with similar functional properties under resting conditions will be detected. This analysis is able to identify significant long-lasting effects of active stimulation (vs. sham) on brain connectivity.
Measured: Compared during each visit between baseline and 30 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start5 Aug 2022
- Primary completion3 Apr 2023
- Study completion3 Apr 2023
Why it stopped: Lack of sufficient personnel to run this study's research visits.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-associated Memory ImpairmentStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The purpose of this study is to understand how Transcranial Magnetic Stimulation(TMS) synchronized with a memory event can enhance working memory capacity. For this purpose, we will synchronize hippocampal directed stimulation, primary motor cortex stimulation and sham stimulation at Inter Stimulus Interval (ISI) 200 and 0 ms. The effects on memory will be assessed by a working memory task and resting state functional MRI .
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Pons, Shirley Ryan AbilityLab
- Investigators
- Jose L Pons, Ph.D, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462782
- Sponsor's protocol ID
- STU00216935
- Status last verified
- May 2023
- First submitted
- 17 Jun 2022
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Only authorized personal listed on this IRB will have access to the data. During and after the study, all study records will be assigned a unique subject identifier code to protect the confidentiality of the participant's personal information. The information will be labeled with an unidentifiable code to reduce the risks to participant privacy. Once research information has been collected, we may share some of it. Any research information shared with people outside of Shirley Ryan AbilityLab/Northwestern University will not contain the participant's name, address, telephone or social security number, or any other direct personal identifier unless disclosure of the direct identifier is required by law.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task Paired Transcranial Magnetic Stimulation for Working Memory Potentiation
- ClinicalTrials.gov ID
- NCT05462782
- Acronym / sponsor ID
- STU00216935
- Conditions
- Age-associated Memory Impairment
- Keywords
- Transcranial Magnetic Stimulation, Paired Associative Stimulation, Working Memory, Older adults, Functional Magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of sufficient personnel to run this study's research visits.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 3 Apr 2023 (actual)
- First posted
- 18 Jul 2022 (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 aim of this study is to investigate the effects of Transcranial Magnetic Stimulation (TMS) following a Paired Associative Stimulation (PAS) protocol on the memorization capacity of elderly individuals. For this purpose, we will apply TMS synchronized with a working memory (WM) task and assess its effects on cortical connectivity and memorization capacity by Magnetic Resonance Imaging (MRI) and WM task learning. This study will be carried out in an older population of healthy participants. We will use the study results to refine the task related PAS protocol towards enhancing memory performance and brain connectivity.
Detailed description
The fundamental objective is to evaluate the changes derived from the specific Paired Associative Stimulation (PAS) protocol applying Transcranial Magnetic Stimulation (TMS) towards the hippocampus to enhance memory in an older population. We will evaluate the following effects: 1) Changes in memory capacity using task performance of the working memory (WM) task and calculating the correctly memorized items; and 2) Changes in brain connectivity using resting state functional Magnetic Resonance Imaging (rs-fMRI) and comparing the correlated activity between areas related to the process of memorization.
In order to understand the memory and brain connectivity changes derived from the PAS intervention more specifically, we will characterize the stimulation localization, the Inter Stimulus Interval (ISI) timing and rule out training and placebo effects. To research if the PAS effects are specific to the stimulated brain area, we will conduct a control group in which stimulation will be delivered to the primary motor area (M1). Then, we will compare the outcome measures (changes in memory capacity and brain connectivity) between the different brain areas. To characterize the ISI, our goal is to calculate the synchronization timing that triggers cortical plastic changes. Thus, we will test two different ISI between the TMS pulse delivery and memorization task. Finally, to differentiate the effects that are derived from the PAS versus the effects from repetition of the task or placebo effects, we will conduct another control group with Sham TMS stimulation and reproduce the same experimental procedures as the group that receives the TMS stimulation. Sham TMS is used in this study to compare if brain stimulation (active TMS) can help improve memory compared to receiving no brain stimulation (sham TMS).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The purpose of this study is to understand how Transcranial Magnetic Stimulation(TMS) synchronized with a memory event can enhance working memory capacity. For this purpose, we will synchronize hippocampal directed stimulation, primary motor cortex stimulation and sham stimulation at Inter Stimulus Interval (ISI) 200 and 0 ms. The effects on memory will be assessed by a working memory task and resting state functional MRI .
| Arm | Type | Receives |
|---|---|---|
| Active TMS | Experimental | Device: Transcranial Magnetic Stimulation (TMS) Cone CoilOlder healthy participants will be scanned with MRI and undergo memory task synchronized PAS with an active TMS in each visit with different stimulation localization and ISIs. |
| Sham TMS | Sham comparator | Device: Transcranial Magnetic Stimulation (TMS) Sham CoilOlder healthy participants will be scanned with MRI and undergo memory task synchronized PAS with a sham TMS coil in each visit with different ISIs application. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age from 60 to 85 years, inclusive (For piloting purposes, this inclusion criteria may vary).
- No history of a brain and/or skull lesion (e.g., stroke)
- Normal vision (can be corrected)
- Able to understand and give informed consent
- No neurological disorders
Key exclusion criteria (20 listed)
- Cardiac pacemaker or pacemaker wires; neurostimulators; implanted pumps
- Metal in the body (rods, plates, screws, shrapnel, dentures, IUD) or metallic particles in the eye
- Surgical clips in the head or previous neurosurgery
- Any magnetic particles in the body
- Cochlear implants
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 Magnetic Stimulation (TMS) Cone CoilThe cone coil Cool-DB80 (MagPro, MagVenture, Alpharetta GA, US) will be used with an MRI-based TMS navigation system (Localite, St Augustin, Germany). TMS interventions will involve the following parameters: 1. Hippocampal directed stimulation at ISI 0ms, 2. Hippocampal directed stimulation at ISI 200ms, 3. Motor cortex stimulation at ISI 0ms, and 4. Motor cortex stimulation at ISI 200ms. | Device | Active TMS |
| Transcranial Magnetic Stimulation (TMS) Sham CoilThe sham coil Cool B65 A/P (MagPro, MagVenture, Alpharetta GA, US) will be used with an MRI-based TMS navigation system (Localite, St Augustin, Germany). The different TMS interventions will be involve the following parameters: 1. Sham stimulation at ISI 0ms, and 2. Sham stimulation at ISI 200ms. | Device | Sham TMS |
Primary outcome
Changes in Working Memory (WM) capacity
Time frame: Compared during each visit between baseline, immediately after the intervention, and 30 minutes after intervention
The WM task utilized is a customized version of the masking task model, presented by Sana Inoue and Tetsuro Matsuzawa, in 2007. This task is organized in three phases: 1) Waiting phase: a visual cue is presented to indicate the initiation of the trial; 2) Coding and retention phase: numbers are presented in a random arrangement within a 5x5 square matrix; and 3) Recall phase: the numbers disappear, leaving a white background as a clue, and the subject completes the task by pressing the squares in the matrix following the incremental order of the numbers. (Figure 2). The task ends either when the subject makes a mistake or completes correctly selecting all numbers in incremental order. The outcome measure for WM capacity is the amount of correctly remembered items (hit items) of each trial.
Changes in resting state functional MRI connectivity
Time frame: Compared during each visit between baseline and 30 minutes after intervention
The neural connectivity index that we will assess responds to the strength of synaptic connections between neurons and over time. The identification of correlations between remote brain areas will be tested by resting state functional magnetic resonance imaging (rs-fMRI). We will compare the connectivity network after intervention time with baseline and sham group. Correlations of spontaneous modulations in the blood oxygen level dependent (BOLD) signal will be analyzed and regions with similar functional properties under resting conditions will be detected. This analysis is able to identify significant long-lasting effects of active stimulation (vs. sham) on brain connectivity.
Results and safety
The study was stopped early (reason given: Lack of sufficient personnel to run this study's research visits.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: No. Only authorized personal listed on this IRB will have access to the data. During and after the study, all study records will be assigned a unique subject identifier code to protect the confidentiality of the participant's personal information. The information will be labeled with an unidentifiable code to reduce the risks to participant privacy. Once research information has been collected, we may share some of it. Any research information shared with people outside of Shirley Ryan AbilityLab/Northwestern University will not contain the participant's name, address, telephone or social security number, or any other direct personal identifier unless disclosure of the direct identifier is required by law.
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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.
Jose L Pons, Ph.D principal investigator
Shirley Ryan AbilityLab
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 Magnetic Stimulation (TMS) Cone Coil in people with Age-associated Memory Impairment, run by Shirley Ryan AbilityLab 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 6 inclusion and 20 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: stopped early, as of the sponsor's last update on 1 Jun 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?
The study was stopped early (reason given: Lack of sufficient personnel to run this study's research visits.). Results are not available in the source record.
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?
Changes in Working Memory (WM) capacity (time frame: Compared during each visit between baseline, immediately after the intervention, and 30 minutes after intervention). 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?
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 1 Jun 2023.