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Non-invasive Brain Stimulation

Transcranial Magnetic Stimulation for Cognitive Impairment

N/A

Waitlist Available

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All participants must be native English speakers

Participants must be between the ages of 60-85

Must not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 weeks

Summary

This trial will study the effects of brain stimulation on memory in cognitively unimpaired older adults and in patients with mild cognitive impairment due to Alzheimer's disease.

Who is the study for?

This trial is for older adults aged 60-85 who are native English speakers, can consent to the study, and undergo testing. It includes those with mild cognitive issues due to Alzheimer's but excludes anyone with a history of significant head trauma, other major neurological or psychiatric conditions, brain lesions, MRI contraindications like pacemakers, long-term substance abuse, unstable medical conditions or unwillingness to comply with follow-up tests.

What is being tested?

The trial is examining how non-invasive brain stimulation using repetitive Transcranial Magnetic Stimulation (rTMS) affects memory in aging individuals without cognitive impairment and those with mild Alzheimer's-related impairment. The study will monitor changes in brain network function and memory performance before and after the treatment.

What are the potential side effects?

While not explicitly stated here, common side effects of rTMS may include headache, scalp discomfort at the site of stimulation, tingling or spasms in facial muscles, lightheadedness. However individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a native English speaker.

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I am between 60 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a head injury that made me lose or alter my consciousness.

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I have a diagnosed brain lesion, such as a tumor.

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I cannot have an MRI due to metal in my body or certain medical devices.

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I am willing to return for follow-up and undergo all required tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Face

Secondary study objectives

Changes in intrinsic functional connectivity

Side effects data

From 2005 Phase 2 trial • 50 Patients • NCT00004980

59%

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Active Repetitive Transcanial Magnetic Stimulation

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active stimulationExperimental Treatment1 Intervention

Active rTMS will be administered with a MagPro X100 stimulator (MagVenture, Denmark), using a 70 mm figure-of-eight liquid cooled coil capable of doing active or sham stimulation (e.g. the Cool B70 coil or the Cool B65 A/P coil). Active rTMS will be delivered at 80% of a patient's active motor threshold. rTMS will be administered in an excitatory iTBS pattern. Stimulation parameters will remain well within established safety guidelines (Rossi et al. 2009).

Group II: Sham stimulationPlacebo Group1 Intervention

SHAM stimulation will also be administered with a MagPro X100 stimulator (MagVenture, Denmark), using a 70 mm figure-of-eight liquid cooled coil capable of doing active or sham stimulation (e.g. the Cool B70 coil or the Cool B65 A/P coil). SHAM rTMS will be delivered at 80% of a patient's active motor threshold. SHAM stimulation will be delivered to the exact same cortical targets as active rTMS. While no electromagnetic stimulation will be delivered during SHAM, the sounds will approximate active stimulation and skin electrodes will approximate the sensation of active rTMS. Inclusion of a sham condition in this protocol is critical to measure whether or not the stimulation is improving memory performance, or whether practice effects or other non-specific effects are responsible for any changes in memory which may be observed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

repetitive transcranial magnetic stimulation (rTMS)

2003

Completed Phase 2

~380

0 / 6Eligibility criteria met