Effect of Deep Transcranial Magnetic Stimulation on MemoryEarly Phase 1NCT01599208
Facilitating Associative Memory Via Deep Transcranial Magnetic Stimulation to the Medial Temporal Lobe
A Early Phase 1 study testing TMS in people with Effect of Deep Transcranial Magnetic Stimulation on Memory, run by Brainsway.
Trial summary
The goal of the proposed research is to map the effects-in particular facilitation-of Transcranial Magnetic Stimulation (TMS) of the Medial Temporal Lobes (MTL) onto the processing of associative memory. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Deep Transcranial Magnetic Stimulation on Memory
- What is being tested?
- TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Jun 2015
- Phase
- Early Phase 1
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women aged 18-85
- Answered negatively on safety screening questionnaire for TMS
- Capable and willing to provide informed consent.
- For participants aged more than 65, normal memory scoring should be obtained in a Nexig test.
Who cannot join
- History of epilepsy or seizure or history of such in first degree relatives.
- Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure, or history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes.
- History of head injury necessitating cranial surgery or prolonged coma.
- History of any metal in the head including the eyes and ears (outside the mouth).
- Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps.
- History of severe migraine.
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- History of significant hearing loss.
- Individuals with a significant neurological disorder.
- History of substance abuse including alcoholism within the past 6 months (except nicotine and caffeine)
- Inadequate communication with the participant.
- Participation currently in another clinical study or enrolled in another clinical study within 30 days prior to this study.
- Participants who suffer from an unstable physical, systemic and metabolic disorders
- Women who are breast-feeding
- Known or suspected pregnancy
About this study
The goal of the proposed research is to map the effects-in particular facilitation-of Transcranial Magnetic Stimulation (TMS) of the Medial Temporal Lobes (MTL) onto the processing of associative memory. TMS technology has the potential to selectively enhance functions mediated by areas in the temporal cortex, including the MTL, known to be the primary neuronal seat of episodic memory. By using this technology the investigators can further our understanding of theoretical models of human memory (specifically regarding the role of Recollection and Familiarity processes), and additionally, provide a possible route to the recovery of some of memory loss typically observed in the elderly-namely, memory for associations. Given the MTL's critical role in human memory and facilitation-inducing qualities of TMS, this research goal is to provide a nonintrusive tool to facilitate memory performance in young and elderly healthy participants.
Read the detailed description
Our theoretical motivation is to explore the mechanisms underlying recognition memory. Evidence from a variety of paradigms has converged on the notion that recognition memory comprises two processes:
- Familiarity, entails item-specific information.
- Recollection, entails association-specific information. Evidence suggests that recollection is associated with a network of neuronal regions, including the anterior medial prefrontal cortex, lateral parietal cortex, and the hippocampus. Familiarity, in contrast, is associated with the lateral prefrontal cortex and the peripheral cortex. Critically, for both familiarity and recollection, the vital role of the MTL is strongly implicated. To dissociate between recollection and familiarity, despite stimulating the same location in the brain, the investigators take into account the difference in processing time in which these two processes are known to operate, and use both objective and subjective cognitive tasks to accurately measure effects.
In addition, this research has clinical motivation, which relates to the nature of memory decline in the elderly. If successful, the investigators will be able to set an effective TMS protocol that could be used as a tool to enhance the very types of memories-association-specific memories-that are thought to mediate poor memory performance in the elderly.
To achieve both goals, the proposed experiments will target the MTL using both online stimulation (short-duration stimulation during the presentation of stimuli in recognition memory test) that will enable us to differentiate between effects of familiarity and recollection and offline stimulation mode (repetitive stimulation of several minutes separately from the recognition memory test), with the goal of achieving facilitation effects on memory performance.
- Being tested
- TMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
TRANSCRANIAL MAGNETIC STIMULATION
| Study group | Role | What they receive |
|---|---|---|
| Single-pulse online stimulation | Experimental | Online single-pulse online stimulation at 120% of motor threshold to either the right or left MTL, in comparison to sham condition, in either -400/0/400/800 ms relatively to stimulus in either the study or test phases of a recognition test. Receives: Device: TMS |
| Repetitive online stim., 400ms, 10Hz | Experimental | Repetitive online stimulation for 400ms at 10Hz at 120% of motor threshold to either the right or left MTL, in comparison to sham condition, in either -400/0/400/800 ms relatively to stimulus in either the study or test phases of a recognition test. Receives: Device: TMS |
| Repetitive online stim., 400ms, 20Hz | Experimental | Repetitive online stimulation for 400ms at 20Hz at 120% of motor threshold to either the right or left MTL, in comparison to sham condition, in either -400/0/400/800 ms relatively to stimulus in either the study or test phases of a recognition test. Receives: Device: TMS |
| Repetitive offline stimulation at 10Hz | Experimental | Repetitive offline stimulation at 10Hz for 4 min before study or for 8 min before test (in accordance with the phase length), comprising 2-second stimulation trains and 20-second breaks. Stimulation will be given at 120% of motor threshold to either the right or the left MTL in comparison to sham condition. Receives: Device: TMS |
| Repetitive offline stimulation at 20Hz | Experimental | Repetitive offline stimulation at 20Hz for 4 min before study or for 8 min before test (in accordance with the phase length), comprising 2-second stimulation trains and 20-second breaks. Stimulation will be given at 120% of motor threshold to either the right or the left MTL in comparison to sham condition. Receives: Device: TMS |
| Repetitive offline stimulation with iTBS | Experimental | Repetitive offline stimulation with Intermittent Theta Burst Stimulation (iTBS) comprising 3 pulses at 50Hz, repeated at 5Hz for 2-second stimulation trains with 8-second breaks for 192 seconds. Stimulation will be given at 90% of motor threshold to either the right or the left MTL in comparison to sham condition. Receives: Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in memory based on the timeframe of the online stimulation
For the online stimulation arms, we expect to find a change in memory based on the timeframe of the online stimulation and the cognitive task, namely, we expect to find change in memory for associations when stimulation is at around 800ms, and expect a change in memory for items when stimulation is at around 400ms.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2015 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: no IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Deep Transcranial Magnetic Stimulation on MemoryStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brainsway
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yonatan Goshen, Prof., Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599208
- Sponsor's protocol ID
- TMS-MEMORY-1
- Status last verified
- Jan 2018
- First submitted
- 7 May 2012
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Associative Memory Via Deep Transcranial Magnetic Stimulation to the Medial Temporal Lobe
- ClinicalTrials.gov ID
- NCT01599208
- Acronym / sponsor ID
- TMS-MEMORY-1
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BrainswayIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 15 May 2012 (estimated)
- 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 goal of the proposed research is to map the effects-in particular facilitation-of Transcranial Magnetic Stimulation (TMS) of the Medial Temporal Lobes (MTL) onto the processing of associative memory. TMS technology has the potential to selectively enhance functions mediated by areas in the temporal cortex, including the MTL, known to be the primary neuronal seat of episodic memory. By using this technology the investigators can further our understanding of theoretical models of human memory (specifically regarding the role of Recollection and Familiarity processes), and additionally, provide a possible route to the recovery of some of memory loss typically observed in the elderly-namely, memory for associations. Given the MTL's critical role in human memory and facilitation-inducing qualities of TMS, this research goal is to provide a nonintrusive tool to facilitate memory performance in young and elderly healthy participants.
Detailed description
Our theoretical motivation is to explore the mechanisms underlying recognition memory. Evidence from a variety of paradigms has converged on the notion that recognition memory comprises two processes:
- Familiarity, entails item-specific information.
- Recollection, entails association-specific information. Evidence suggests that recollection is associated with a network of neuronal regions, including the anterior medial prefrontal cortex, lateral parietal cortex, and the hippocampus. Familiarity, in contrast, is associated with the lateral prefrontal cortex and the peripheral cortex. Critically, for both familiarity and recollection, the vital role of the MTL is strongly implicated. To dissociate between recollection and familiarity, despite stimulating the same location in the brain, the investigators take into account the difference in processing time in which these two processes are known to operate, and use both objective and subjective cognitive tasks to accurately measure effects.
In addition, this research has clinical motivation, which relates to the nature of memory decline in the elderly. If successful, the investigators will be able to set an effective TMS protocol that could be used as a tool to enhance the very types of memories-association-specific memories-that are thought to mediate poor memory performance in the elderly.
To achieve both goals, the proposed experiments will target the MTL using both online stimulation (short-duration stimulation during the presentation of stimuli in recognition memory test) that will enable us to differentiate between effects of familiarity and recollection and offline stimulation mode (repetitive stimulation of several minutes separately from the recognition memory test), with the goal of achieving facilitation effects on memory performance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Single-pulse online stimulation | Experimental | Device: TMSOnline single-pulse online stimulation at 120% of motor threshold to either the right or left MTL, in comparison to sham condition, in either -400/0/400/800 ms relatively to stimulus in either the study or test phases of a recognition test. |
| Repetitive online stim., 400ms, 10Hz | Experimental | Device: TMSRepetitive online stimulation for 400ms at 10Hz at 120% of motor threshold to either the right or left MTL, in comparison to sham condition, in either -400/0/400/800 ms relatively to stimulus in either the study or test phases of a recognition test. |
| Repetitive online stim., 400ms, 20Hz | Experimental | Device: TMSRepetitive online stimulation for 400ms at 20Hz at 120% of motor threshold to either the right or left MTL, in comparison to sham condition, in either -400/0/400/800 ms relatively to stimulus in either the study or test phases of a recognition test. |
| Repetitive offline stimulation at 10Hz | Experimental | Device: TMSRepetitive offline stimulation at 10Hz for 4 min before study or for 8 min before test (in accordance with the phase length), comprising 2-second stimulation trains and 20-second breaks. Stimulation will be given at 120% of motor threshold to either the right or the left MTL in comparison to sham condition. |
| Repetitive offline stimulation at 20Hz | Experimental | Device: TMSRepetitive offline stimulation at 20Hz for 4 min before study or for 8 min before test (in accordance with the phase length), comprising 2-second stimulation trains and 20-second breaks. Stimulation will be given at 120% of motor threshold to either the right or the left MTL in comparison to sham condition. |
| Repetitive offline stimulation with iTBS | Experimental | Device: TMSRepetitive offline stimulation with Intermittent Theta Burst Stimulation (iTBS) comprising 3 pulses at 50Hz, repeated at 5Hz for 2-second stimulation trains with 8-second breaks for 192 seconds. Stimulation will be given at 90% of motor threshold to either the right or the left MTL in comparison to sham condition. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy men and women aged 18-85
- Answered negatively on safety screening questionnaire for TMS
- Capable and willing to provide informed consent.
- For participants aged more than 65, normal memory scoring should be obtained in a Nexig test.
Key exclusion criteria (14 listed)
- History of epilepsy or seizure or history of such in first degree relatives.
- Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure, or history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes.
- History of head injury necessitating cranial surgery or prolonged coma.
- History of any metal in the head including the eyes and ears (outside the mouth).
- Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps.
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 |
|---|---|---|
| TMSTRANSCRANIAL MAGNETIC STIMULATION | Device | Repetitive offline stimulation at 10Hz, Repetitive offline stimulation at 20Hz, Repetitive offline stimulation with iTBS, Repetitive online stim., 400ms, 10Hz, Repetitive online stim., 400ms, 20Hz, Single-pulse online stimulation |
Primary outcome
Change in memory based on the timeframe of the online stimulation
Time frame: One year
For the online stimulation arms, we expect to find a change in memory based on the timeframe of the online stimulation and the cognitive task, namely, we expect to find change in memory for associations when stimulation is at around 800ms, and expect a change in memory for items when stimulation is at around 400ms.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
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.
Yonatan Goshen, Prof. principal investigator
Tel Aviv University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing TMS in people with Effect of Deep Transcranial Magnetic Stimulation on Memory, run by Brainsway.
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 4 inclusion and 14 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: withdrawn, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in memory based on the timeframe of the online stimulation (time frame: One year). 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 25 Jan 2018.