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Transcranial Magnetic Stimulation

TMS + CILT for Alzheimer's Disease

Phase 1

Waitlist Available

Led By H. Branch Coslett, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

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

Must have

A diagnosis of mild-moderate AD as defined by the National Institute of Aging - Alzheimer's Disease and Related Disorders Association criteria

Must be a native English speaker

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-months post-treatment

Awards & highlights

Study Summary

This trial will test whether transcranial magnetic stimulation (TMS) combined with Constraint Induced Language Therapy (CILT) can improve verbal communication in patients with Alzheimer Disease (AD).

Who is the study for?

This trial is for right-handed, native English speakers with mild to moderate Alzheimer's Disease (AD), having MMSE scores between 23 and 15. Participants must understand the study and consent. Excluded are those with a history of stroke, seizure, other major neurological diseases, significant depression or medical conditions that may interfere with the study.Check my eligibility

What is being tested?

The trial tests if Transcranial Magnetic Stimulation (TMS) combined with Constraint Induced Language Therapy (CILT) can improve verbal communication in AD patients more effectively than sham TMS plus CILT. It also uses advanced neuroimaging to explore how this treatment works.See study design

What are the potential side effects?

Potential side effects from TMS may include discomfort at the stimulation site, headache, lightheadedness, or seizures; however these are generally rare. The specifics of any additional side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with mild to moderate Alzheimer's disease.

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I am a native English speaker.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-months post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in WAB-AQ

Secondary outcome measures

Change in PNT

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active TMSActive Control2 Interventions

There will be 10 TMS sessions over 2 consecutive weeks in which 30 two-second stimulation trains of 10 Hz TMS will be delivered every 30 seconds to the left inferior pars triangularis and to the left posterior superior left temporal gyrus. Each TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).

Group II: Sham TMSPlacebo Group2 Interventions

There will be 10 TMS sessions over 2 consecutive weeks in which 30 two-second stimulation trains of 10 Hz sham TMS will be delivered every 30 seconds to the left inferior pars triangularis and to the left posterior superior left temporal gyrus. Sham TMS will be administered with a sham TMS coil that looks and sounds like the active coil but does not generate a magnetic field. Each TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).

0 / 2Eligibility criteria met

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Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,880,058 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,558 Total Patients Enrolled

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH

327 Previous Clinical Trials

178,185 Total Patients Enrolled

Media Library

Active TMS (Transcranial Magnetic Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04482179 — Phase 1

Alzheimer's Disease Research Study Groups: Active TMS, Sham TMS

Alzheimer's Disease Clinical Trial 2023: Active TMS Highlights & Side Effects. Trial Name: NCT04482179 — Phase 1

Active TMS (Transcranial Magnetic Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04482179 — Phase 1

Frequently Asked Questions

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

Does this experiment currently entertain applications?

"Affirmative, the clinicaltrials.gov portal reveals that this experiment is presently searching for participants. It was initially posted on February 19th 2020 and has since been modified in August 15th 2022. 30 people are needed at 1 trial sites."

Answered by AI

Do I fulfill the requirements for this medical research?

"This medical trial is looking for 30 individuals between the ages of 60 and 85 who are diagnosed with Alzheimer's disease."

Answered by AI

What is the scope of participation in this research project?

"Affirmative. Records hosted on clinicaltrials.gov verify that this medical trial, which was introduced publicly on February 19th 2020, is presently recruiting participants. The study needs to recruit 30 individuals from 1 particular site."

Answered by AI

How perilous is Transcranial Magnetic Stimulation for individuals?

"Based on our assessment, Active TMS received a score of 1 as this is an introductory study with limited supporting evidence for safety and efficacy."

Answered by AI

Are adults aged 25 and above eligible to participate in this trial?

"This medical trial requires that participants be aged between 60 and 85 years old. For those under 18, there are 23 similar trials available; whereas for people over 65, 536 trials can offer suitable options."

Answered by AI