TMS for Cognitive Decline in Aging and Preclinical AD

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-99
SponsorMassachusetts General Hospital

About 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 accepts healthy volunteers

Qualifiers

Between the ages of 40-99

Native English speakers

Willing and able to consent to the protocol and undergo imaging and neuropsychological testing at the specified time points

Cognitively normal older adults and individuals with preclinical Alzheimer's disease will be included.

Disqualifiers

History of head trauma involving loss of consciousness or alteration in consciousness

Another major neurologic or psychiatric condition

Known presence of a structural brain lesion (e.g. tumor, cortical infarct)

Any contraindication to MRI, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body

Trial design

Design model

Crossover

Treatments tested in this trial

  • Active rTMS

    Device

    All study participants will receive one block of ACTIVE rTMS. Each block will consist of daily sessions of active rTMS delivered to the left dorsolateral prefrontal cortex over ten days (Monday through Friday).

  • Sham rTMS

    Device

    All study participants will receive one block of SHAM rTMS. Each block will consist of daily sessions of SHAM rTMS delivered to the left dorsolateral prefrontal cortex over ten days (Monday through Friday).

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Active TMSExperimental treatment 1 intervention
Group B: Sham TMSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in motivation

This will be measured by ratings of grit on a 5-point scale using the Grit Scale (Duckworth, et al., 2007).

Time frame
Baseline and post-treatment Day 11
2

Changes in Brain Network Connectivity

This will include changes in resting-state functional connectivity measured with functional Magnetic Resonance Imaging (fMRI)

Time frame
Baseline and post-treatment Day 11
3

Changes in Memory

This will be measured with an associative memory task

Time frame
Baseline and Post-Treatment Day 11

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Harvard Medical School (HMS and HSDM)

Sponsor institution