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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
Select...
I am between 60 and 85 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Face
Secondary outcome measures
Changes in intrinsic functional connectivity

Side effects data

From 2005 Phase 2 trial • 50 Patients • NCT00004980
59%
Headache
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,461 Total Patients Enrolled

Media Library

rTMS (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04294888 — N/A
Alzheimer's Disease Research Study Groups: Active stimulation, Sham stimulation
Alzheimer's Disease Clinical Trial 2023: rTMS Highlights & Side Effects. Trial Name: NCT04294888 — N/A
rTMS (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04294888 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity for me to participate in this experiment?

"This research endeavour is looking for 40 elderly individuals, aged 60-85 and diagnosed with Alzheimer's disease. Furthermore, the chosen participants must be English speaking, able to provide consent forms at relevant times, bring an accompanying study partner if they have MCI symptoms, and show very mild or mild cognitive impairment (CDR 0.5 or CDR 1)."

Answered by AI

What is the scope of the participants in this research endeavor?

"Confirmed. Clinicaltrials.gov attests to the present recruitment of participants in this medical experiment, which was first posted on March 2nd 2020 and recently updated on March 11th 2020. 40 patients are being sought from one study site."

Answered by AI

Are there any opportunities for patients to join this research endeavor?

"Affirmative. According to clinicaltrials.gov, this experimental research is currently seeking volunteers and was initially posted on March 2nd 2020 before the most recent update on March 11th 2020. 40 patients will be accepted at a single site for this trial."

Answered by AI

Are elderly participants eligible to enrol in this clinical trial?

"The enrolment requirements for this particular clinical trial restricts participants to those aged 60 and 85. In contrast, 45 studies are recruiting patients who have not yet reached the age of majority while 1145 trials accept seniors over 65 years old."

Answered by AI

Who else is applying?

What site did they apply to?
Massachuetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I was diagnosed in a aducanumab study.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
TMS in Preclinical and Prodromal AD: Modulation of Brain Networks and Memory
Jessica A. Collins, PhD 2020. "TMS in Preclinical and Prodromal AD: Modulation of Brain Networks and Memory". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04294888.
All > Memory
~8 spots leftby Apr 2025
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