Transcranial Magnetic Stimulation Treatment for Alzheimer's Disease
Trial statusRecruiting
Trial phaseEarly Phase 1
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 memory and brain-network function in cognitively unimpaired older adults and in patients with amnestic mild cognitive impairment (aMCI).
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 memory. Changes resulting from this stimulation will be measured with behavioral tests of memory and general cognition, as well as by taking images of your brain 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 volunteersQualifiers
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
Patients with PPA will be asked to bring a study partner to all visits
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
Single group
Treatments tested in this trial
Active rTMS
DeviceAll 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
DeviceAll 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
30 Participants
are divided into 1 treatment groupGroup A: AD, aMCI, lvPPA patients, and preclinical ADExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Changes in Memory
This will include observed changes in memory as a result of the stimulation through neuropsychological testing.
Time frame
Baseline and post-treatment Day 112
Changes in Brain Network Connectivity
This will include observed changes in resting-state functional connectivity as a result of the stimulation.
Time frame
Baseline and post-treatment Day 11Sponsors 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
Source ClinicalTrials.gov