80 Participants Needed

TMS for Cognitive Decline

AT
AD
Overseen ByAnna Du, BA
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that can cause seizures, like clozapine or high doses of bupropion.

What data supports the effectiveness of the treatment Active rTMS for cognitive decline?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can improve cognitive function in older adults with cognitive impairment and Alzheimer's disease. In one study, patients receiving real rTMS showed a trend toward improved cognitive scores, suggesting potential benefits for cognitive decline.12345

Is repetitive transcranial magnetic stimulation (rTMS) safe for humans?

Repetitive transcranial magnetic stimulation (rTMS) has been used safely in both healthy individuals and those with various brain conditions since the 1990s. While it can cause some adverse events like seizures, safety guidelines have been established and updated over the years to minimize risks. Generally, rTMS is considered safe when used according to these guidelines.678910

How does the treatment rTMS differ from other treatments for cognitive decline?

Repetitive transcranial magnetic stimulation (rTMS) is unique because it uses magnetic fields to stimulate specific areas of the brain, which can improve cognitive functions like memory and attention. Unlike medications, rTMS is non-invasive and does not involve taking drugs, making it a novel option for those with cognitive decline.134511

What is the purpose of this trial?

In this research study we want to learn more about the effects of non-invasive brain stimulation on motivation, memory, and brain-network function in cognitively unimpaired older adults and individuals with preclinical Alzheimer's disease.This study will use a form of non-invasive brain stimulation called repetitive Transcranial Magnetic Stimulation (rTMS). rTMS will slightly alter activity in an area of your brain that controls cognition. Changes resulting from this stimulation will be measured with behavioral tests, as well as by taking brain images with Magnetic Resonance Imaging (MRI).Participants will come in for one baseline visit followed by 10 days of daily rTMS study visits (Monday through Friday) and an evaluation visit. Then, there will be a 2-week break. After this break, they will return for another baseline visit, an additional 10 days of rTMS, and a final evaluation visit.

Eligibility Criteria

This trial is for older adults who are either cognitively healthy or have mild cognitive impairment, which can be an early sign of Alzheimer's. Participants should not have any serious medical conditions and must be able to attend multiple study visits over several weeks.

Inclusion Criteria

Willing and able to consent to the protocol and undergo imaging and neuropsychological testing at the specified time points
I am an older adult with normal thinking abilities or have early Alzheimer's without symptoms.
I am a native English speaker.
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Exclusion Criteria

Another major neurologic or psychiatric condition
Longstanding premorbid history (i.e. longer than 10 years) of alcohol or substance abuse with continuous abuse up to and including the time that the symptoms leading to clinical presentation developed
Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline and rTMS Treatment

Participants undergo a baseline visit followed by 10 days of daily rTMS study visits and an evaluation visit

2 weeks
1 baseline visit, 10 daily rTMS visits, 1 evaluation visit

Break

Participants take a 2-week break from the study

2 weeks

Second Baseline and rTMS Treatment

Participants return for another baseline visit, 10 days of rTMS, and a final evaluation visit

2 weeks
1 baseline visit, 10 daily rTMS visits, 1 final evaluation visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Active rTMS
  • Sham rTMS
Trial Overview The study is testing repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive brain stimulation technique, to see if it improves memory and cognition in aging individuals and those with preclinical Alzheimer's disease. It involves daily sessions over two periods of 10 days each.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: CN and participants with preclinical ADExperimental Treatment2 Interventions
All participants will receive the same study interventions in a within-subject crossover design.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Findings from Research

In a pilot study involving 30 Alzheimer's disease patients, focal repetitive transcranial magnetic stimulation (rTMS) using the H2-coil showed a trend toward improved cognitive function, with a mean decrease of -1.01 points on the ADAS-Cog scale after treatment, although this effect was not sustained two months post-treatment.
The study indicates that rTMS with the H2-coil is safe and feasible for Alzheimer's patients, suggesting potential cognitive benefits that warrant further investigation in larger trials, especially when combined with cognitive rehabilitation.
Repetitive Transcranial Magnetic Stimulation With H-Coil in Alzheimer's Disease: A Double-Blind, Placebo-Controlled Pilot Study.Leocani, L., Dalla Costa, G., Coppi, E., et al.[2021]
Repetitive transcranial magnetic stimulation (rTMS) significantly improved cognitive function in older patients with mild to moderate Alzheimer's disease, based on a meta-analysis of seven randomized controlled trials involving 194 participants.
rTMS is considered a safe and well-tolerated alternative intervention for cognitive impairment, showing a moderate effect size in enhancing cognition compared to sham treatments.
Effects of repetitive transcranial magnetic stimulation on improvement of cognition in elderly patients with cognitive impairment: a systematic review and meta-analysis.Cheng, CPW., Wong, CSM., Lee, KK., et al.[2018]
In a study involving 19 middle-aged and elderly patients with refractory depression, those receiving active repetitive transcranial magnetic stimulation (rTMS) showed significant improvements in cognitive flexibility compared to those receiving sham treatment.
The active rTMS was specifically targeted at the anterior portion of the left middle frontal gyrus, suggesting a potential mechanism for enhancing cognitive function in patients with depression.
Improved executive functioning following repetitive transcranial magnetic stimulation.Moser, DJ., Jorge, RE., Manes, F., et al.[2019]

References

Repetitive Transcranial Magnetic Stimulation With H-Coil in Alzheimer's Disease: A Double-Blind, Placebo-Controlled Pilot Study. [2021]
A controlled study of repetitive transcranial magnetic stimulation as a treatment of depression in the elderly. [2022]
Safety and benefits of distance-adjusted prefrontal transcranial magnetic stimulation in depressed patients 55-75 years of age: a pilot study. [2022]
Effects of repetitive transcranial magnetic stimulation on improvement of cognition in elderly patients with cognitive impairment: a systematic review and meta-analysis. [2018]
Improved executive functioning following repetitive transcranial magnetic stimulation. [2019]
Safety of repetitive transcranial magnetic stimulation in patients with implanted cortical electrodes. An ex-vivo study and report of a case. [2019]
Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]
Adverse events of repetitive transcranial magnetic stimulation in older adults with depression, a systematic review of the literature. [2021]
Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. [2022]
The repetitive transcranial magnetic stimulation in Alzheimer's disease patients with behavioral and psychological symptoms of dementia: a case report. [2023]
Transcranial magnetic stimulation (TMS) for geriatric depression. [2023]
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