Expired Study
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Palo Alto, California 94304


Purpose:

The purpose is to is to study if repetitive transcranial magnetic stimulation (rTMS) improves cognitive function in patients with neurodegenerative conditions which may manifest as mild to moderate cognitive impairment and, in late phase, dementia. This study also intends to investigate if the responses to rTMS intervention are either positively or negatively correlated with the initial severity of cognitive impairment.


Study summary:

The primary hypothesis is that rTMS applied to the dorsolateral prefrontal cortex will lead to improved memory, language and executive function compared to patients who receive a sham, control treatment. The improvement is defined as having higher performance on the California Verbal Learning Test (CVLT-II). Secondary Hypotheses are that: - 1: rTMS- will lead to higher performance on secondary cognitive measures relating to executive function and naming compared to performance by participants in the sham treatment group at the termination of treatment; and that - 2: rTMS-induced memory improvement parallels changes in serum and cerebrospinal fluid (CSF) brain-derived neurotrophic factor (BDNF) levels after treatment.


Criteria:

Inclusion Criteria: - Veterans aged 55 years or older - Diagnosed with Mild Cognitive Impairment (MCI) or dementia likely due to Alzheimer's disease. - Ability to obtain a Motor Threshold, determined during the screening process. - With an adequately stable condition and living environment to enable attendance at scheduled clinic visits. - If on a prescription medication for cognition that medication dose will be stable for at least 4 weeks prior to randomization into the study and participant will be willing to remain on a stable regimen during the acute treatment phase. - Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form to be signed by the participant, or a designated legal representative when the participant lacks decision making capacity prior to participating in any study- specific procedures or assessments. Exclusion Criteria: - Patients with prior exposure to rTMS or electroconvulsive therapy (ECT). - Unable to safely withdraw, at least two weeks prior to treatment commencement, from medications that substantially increase the risk of having seizures. - Have a cardiac pacemaker or a cochlear implant. - Have an implanted device deep brain stimulation or metal in the brain - Current substance abuse not including caffeine or nicotine as determined by patient report or chart review. - Active current suicidal intent or plan as determined by patient report or chart review. - Current or Prior history of a seizure disorder as determined by patient report or chart review - Traumatic brain injury within the last two months - Participation in another concurrent interventional clinical trial - Known current psychosis as determined by patient report or chart review. - Current or prior history of a mass lesion, cerebral infarct or other non-cogitative, active central nervous system (CNS) disease that would increase the risk for seizure. - Not fluent in English or a hearing impairment severe enough to impair comprehension


Study is Available At:


Original ID:

E1889-P


NCT ID:

NCT02621424


Secondary ID:

RX14-009


Study Acronym:

rTMS for demen


Brief Title:

Repetitive Transcranial Magnetic Stimulation for Dementia


Official Title:

Repetitive Transcranial Magnetic Stimulation for Dementia


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

55 Years


Maximum Age:

99 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

VA Office of Research and Development


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

62


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Jauhtai J Cheng, MD
Principal Investigator
VA Palo Alto Health Care System, Palo Alto, CA

Study Dates

Start Date:January 1, 2016
Completion Date:February 29, 2020
Completion Type:Anticipated
Primary Completion Date:February 28, 2019
Primary Completion Type:Actual
Verification Date:October 2019
Last Changed Date:October 21, 2019
First Received Date:November 23, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:changes from baseline CVLT scores after treatment and 4 months later
Time Frame:within a week following the final treatment session and 4 month later
Safety Issues:False
Description:California visual learning test- memory, executive
Outcome Type:Secondary Outcome
Measure:changes in Boston Naming after treatment and 4 months later
Time Frame:within a week following the last treatment session and 4 months later
Safety Issues:False
Description:Boston Naming
Outcome Type:Secondary Outcome
Measure:changes in BDNF levels in serum and/or CSF after treatment and 4 months later
Time Frame:within a week following the last treatment session and 4 months later
Safety Issues:False
Description:BDNF levels in serum and/or CSF
Outcome Type:Secondary Outcome
Measure:changes in Animal fluency after treatment and 4 months later
Time Frame:immediately following treatment and 4 months later
Safety Issues:False
Description:Animal fluency
Outcome Type:Secondary Outcome
Measure:changes in Trail making after treatment and 4 months later
Time Frame:immediately following treatment and 4 months later
Safety Issues:False
Description:Trail making

Study Interventions

Intervention Type:Device
Name:RTMS
Description:stimulation of the brain with magnetic pulses
Arm Name:RTMS
Intervention Type:Device
Name:sham
Description:sham noise to block the sound of stimulation
Arm Name:sham

Study Arms

Study Arm Type:Sham Comparator
Arm Name:sham
Description:sham noise to block the sound of treatment
Study Arm Type:Experimental
Arm Name:RTMS
Description:repetitive transcranial magnetic stimulation

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:VA Office of Research and Development

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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