Alzheimer DiseaseTMS_ADNCT04440891
Application of TMS Coupled With VR for Slowing the Rate of Cognitive Decline in Patients With Alzheimer's Disease
A study testing TMS stimulation with X-Torp task and TMS-Stimulation with MindMotion Go in people with Alzheimer Disease, run by Ali Rezai at 1 site in United States.
Trial summary
This is a randomized sham control study to evaluate how repetitive Transcranial Magnetic Stimulation (rTMS), interactive cognitive training, or the combination of rTMS and cognitive training reduce the cognitive decline of patients diagnosed with Alzheimer's disease Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- TMS stimulation with X-Torp task and TMS-Stimulation with MindMotion Go
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2019to 2 Nov 2021
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female between 50-85 years of age
- Able and willing to give informed consent
- Probable AD consistent with NIA/AA criteria
- Modified Hachinski Ischemia Scale (MHIS) score of <= 4
- Geriatric Depression Scale (GDS) score of <= 6
- Mini Mental State Exam (MMSE) score 18-26. The MMSE adjusted scoring instructions may be followed for screening patients as applicable.
Who cannot join
- Unstable medical conditions
- Visual impairments
- Mobility limitations
- Cognition-enhancing medication unless on a stable dosage for at least 3 months before the start of the trial.
- History of epilepsy or seizure disorder
- History of psychosis
Show all 14Show fewer
- Current thoughts of suicidal ideation or self-harm as assessed by the Columbia-Suicide severity rating scale score
- Progressive neurological disorder or focal signs of abnormality on neurological exam as conducted by a neurologist (other than current diagnosis of AD)
- Tinnitus
- Metal implants (excluding dental fillings)
- Possible pregnancy
- Substance use disorder within the past six months
- Have other mental or physical conditions that are inappropriate for study participation at PI's or delegated sub investigator's discretion.
- Intake of one or a combination of the drugs that may due to their significant seizure threshold lowering potential
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University Rockefeller Neuroscience Institute
Morgantown, West Virginia, 26506
About this study
Official title: Application of Transcranial Magnetic Stimulation Coupled With Virtual Reality for Slowing the Rate of Cognitive Decline in Patients With Alzheimer's Disease
This is a randomized sham control study to evaluate how repetitive Transcranial Magnetic Stimulation (rTMS), interactive cognitive training, or the combination of rTMS and cognitive training reduce the cognitive decline of patients diagnosed with Alzheimer's disease
Read the detailed description
Participants may be assigned to one of four experimental arms (1-TMS-Stimulation with X-Torp task, 2-TMS-Stimulation with MindMotion Go, 3-TMS-Sham with X-Torp task, 4-TMS-Sham with MindMotion Go.) The study will be conducted in two phases. During Phase 1, participants will be randomized between experimental conditions 1 and 4. Data will be analyzed upon completion of Phase1 and Phase 2 will commence only if there is efficacy in the TMS arm. During Phase2, participants will be randomized to arms 2 and 3.
- Conditions
- Alzheimer Disease
- Being tested
- TMS stimulation with X-Torp task, TMS-Stimulation with MindMotion Go, TMS-Sham with X-Torp task, TMS-Sham with MindMotion Go
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMS stimulation with X-Torp taskDevice
TMS-Stimulation with X-Torp task
TMS-Stimulation with MindMotion GoDevice
TMS-Stimulation with MindMotion Go
TMS-Sham with X-Torp taskDevice
TMS-Sham with X-Torp task
TMS-Sham with MindMotion GoDevice
TMS-Sham with MindMotion Go
| Study group | Role | What they receive |
|---|---|---|
| TMS-Stimulation with X-Torp task | Experimental | TMS with VR 1 experimental arm Receives: Device: TMS stimulation with X-Torp task |
| TMS-Stimulation with MindMotion Go | Experimental | TMS with VR 2 experimental arm Receives: Device: TMS-Stimulation with MindMotion Go |
| TMS-Sham with X-Torp task | Sham comparator | TMS sham control with VR 1 Receives: Device: TMS-Sham with X-Torp task |
| TMS-Sham with MindMotion Go | Sham comparator | TMS sham control with sham VR 2 Receives: Device: TMS-Sham with MindMotion Go |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Performance
Change in cognitive task performance over time using the total score on the Mini Mental State Examination (range 0-30)
Measured: 6 months after completion study procedure
Secondary outcomes (2)
Brain MRI
Change in brain structure and function over time
Measured: 6 months after completion of study procedure compared to screening
Memory Performance
Total recall on the California Verbal Learning Test - short form (range 0-36)
Measured: 6 months after completion of study procedure compared to screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start3 Oct 2019
- Primary completion2 Nov 2021
- Study completion2 Nov 2021
Why it stopped: Difficulty with recruitment due to Covid. 3 subjects consented but did not start any study procedures or participate in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ali Rezai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ali Rezai, West Virginia University
- Investigators
- Marc Haut, PhD, Study chair, Rockefeller Neuroscience InstituteVictor Finomore, PhD, Study director, Rockefeller Neuroscience Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440891
- Sponsor's protocol ID
- 1904522298
- Acronym
- TMS_AD
- Status last verified
- Aug 2023
- First submitted
- 22 May 2020
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Transcranial Magnetic Stimulation Coupled With Virtual Reality for Slowing the Rate of Cognitive Decline in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04440891
- Acronym / sponsor ID
- TMS_AD / 1904522298
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty with recruitment due to Covid. 3 subjects consented but did not start any study procedures or participate in the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ali RezaiUniversity, hospital or other
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 22 Jun 2020 (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.
This is a randomized sham control study to evaluate how repetitive Transcranial Magnetic Stimulation (rTMS), interactive cognitive training, or the combination of rTMS and cognitive training reduce the cognitive decline of patients diagnosed with Alzheimer's disease
Detailed description
Participants may be assigned to one of four experimental arms (1-TMS-Stimulation with X-Torp task, 2-TMS-Stimulation with MindMotion Go, 3-TMS-Sham with X-Torp task, 4-TMS-Sham with MindMotion Go.) The study will be conducted in two phases. During Phase 1, participants will be randomized between experimental conditions 1 and 4. Data will be analyzed upon completion of Phase1 and Phase 2 will commence only if there is efficacy in the TMS arm. During Phase2, participants will be randomized to arms 2 and 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TMS-Stimulation with X-Torp task | Experimental | Device: TMS stimulation with X-Torp taskTMS with VR 1 experimental arm |
| TMS-Stimulation with MindMotion Go | Experimental | Device: TMS-Stimulation with MindMotion GoTMS with VR 2 experimental arm |
| TMS-Sham with X-Torp task | Sham comparator | Device: TMS-Sham with X-Torp taskTMS sham control with VR 1 |
| TMS-Sham with MindMotion Go | Sham comparator | Device: TMS-Sham with MindMotion GoTMS sham control with sham VR 2 |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female between 50-85 years of age
- Able and willing to give informed consent
- Probable AD consistent with NIA/AA criteria
- Modified Hachinski Ischemia Scale (MHIS) score of <= 4
- Geriatric Depression Scale (GDS) score of <= 6
Key exclusion criteria (14 listed)
- Unstable medical conditions
- Visual impairments
- Mobility limitations
- Cognition-enhancing medication unless on a stable dosage for at least 3 months before the start of the trial.
- History of epilepsy or seizure disorder
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 |
|---|---|---|
| TMS stimulation with X-Torp taskTMS-Stimulation with X-Torp task | Device | TMS-Stimulation with X-Torp task |
| TMS-Stimulation with MindMotion GoTMS-Stimulation with MindMotion Go | Device | TMS-Stimulation with MindMotion Go |
| TMS-Sham with X-Torp taskTMS-Sham with X-Torp task | Device | TMS-Sham with X-Torp task |
| TMS-Sham with MindMotion GoTMS-Sham with MindMotion Go | Device | TMS-Sham with MindMotion Go |
Primary outcome
Cognitive Performance
Time frame: 6 months after completion study procedure
Change in cognitive task performance over time using the total score on the Mini Mental State Examination (range 0-30)
2 secondary outcomes
Brain MRI
Time frame: 6 months after completion of study procedure compared to screening
Memory Performance
Time frame: 6 months after completion of study procedure compared to screening
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 14 Aug 2023.
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
Marc Haut, PhD study chair
Rockefeller Neuroscience Institute
Victor Finomore, PhD study director
Rockefeller Neuroscience Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS stimulation with X-Torp task and TMS-Stimulation with MindMotion Go in people with Alzheimer Disease, run by Ali Rezai 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 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 14 Aug 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 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?
Cognitive Performance (time frame: 6 months after completion study procedure). 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 14 Aug 2023.