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Network-targeted Theta-burst Stimulation for Episodic Memory Improvement in Mild Cognitive Impairment

Primary Purpose

Cognitive Dysfunction, Memory Disorders in Old Age

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Active Theta Burst Stimulation

Sham Theta Burst Stimulation

About this trial

This is an interventional treatment trial for Cognitive Dysfunction

Eligibility Criteria

55 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

55-90 years of age
Right-handedness
Willing to provide informed consent and participate in a longitudinal study
In good general health
Ability to read, write, and speak English fluently
Adequate visual and auditory acuity to allow neuropsychological testing
Screening laboratory/ECG without abnormalities that might interfere with the study
Diagnosis of mild neurocognitive disorder according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria
Living independently
Subjective memory complaints (self-report and positive score on MFQ)
Katz ADL scale: We will exclude potential volunteers scoring < 6
Lawton iADL scale: We will exclude potential volunteers scoring < 8 (however, having points off is OK if the volunteer never did a task even prior to memory loss (e.g., more men than women never shopped, did laundry, or cooked due to stereotypical social roles). In such an example, the volunteer could score as low as 5 and still be included (no points off for the three activities never done before memory loss).
MMSE score > 24
PHQ score > 7
Hamilton Depression score < 7
No change in use of psychotropic medication for treatment of depression, anxiety, ADHD or psychosis 1 month prior and during the study.
At least 1 Standard Deviation below the mean in 2 out of the 3 following tests: BVMT-R (25-minute delay), CVLT-II (20-minute delay), Rey-Osterrieth Complex Figure Task (30-minute delay).

Exclusion Criteria:

Diagnosis of dementia
Unwilling or unable to provide informed consent
Active major psychiatric or neurologic disorders associated with neurocognitive impairment
Active or history of alcohol or substance abuse
Recent (< 6 months) alcohol or substance abuse excluding nicotine or caffeine
Active or history of stroke, traumatic brain injury with loss of consciousness, or other neurologic disorder (e.g., Epilepsy, Huntington's disease, Parkinson's disease)
Non-English speaking participants
Not right handed based on self-report or evaluation based on a standard report
Has received TMS before (not TMS naïve)
Head trauma or systemic diseases affecting brain function
Sleep deprivation
Uncontrolled hypertension or cardiovascular disease
is taking:
- anticholinergic medication (e.g., Detrol, Cogentin);
- sedating antihistamine (e.g., Benadryl);
- any drug that has significant anticholinergic or antihistaminic side effects (e.g., tricyclic antidepressant medications, Remeron).
- Benzodiazepines. While not a strict rule out, this will be decided on a case-by-case basis depending on the dose.
Current enrollment in a memory-enhancement study or course
Contraindication to the MRI including claustrophobia, metal in body, surgery within 60 days, certain implants or previous abnormal MRI results.

Sites / Locations

University of California Los AngelesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active TBS

Sham TBS

Arm Description

Theta burst stimulation (TBS) will be delivered at 100% of motor threshold (MT).

Sham stimulation will be delivered at 0% of motor threshold (MT), with all other parameters matching the active TBS condition.

Outcomes

Primary Outcome Measures

Verbal recall performance change

Verbal memory will be measured using a free recall task where participants learn a list of everyday words and are asked to recall as many words as they can remember after a period of distraction. Proportion of recollected words will be used to quantify memory performance changes.

Object recognition memory performance change

Object memory will be measured using an recognition task where participants view photos of everyday objects and are asked to identify them as OLD or NEW during a memory test wherein unseen novel objects and very similar but new photos of identical objects are shown. Recollection and discrimination index will be used to quantify memory performance changes.

Associative memory performance change

Associative memory will be tested using the Face Name Memory Test wherein participants are shown faces and associated names. Participants are then shown faces only and asked to recall the associated name.

Secondary Outcome Measures

Resting state fMRI functional connectivity

Resting state fMRI activity will be measured before the first and after the last TBS treatment

EEG activity

EEG functional connectivity with stimulated region and medial temporal source localized power in the theta band will be recorded during a resting period as well as during the treatment itself both before and after treatments

Full Information

NCT ID

NCT04558164

First Posted

September 4, 2020

Last Updated

September 12, 2023

Sponsor

University of California, Los Angeles

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT04558164

Brief Title

Network-targeted Theta-burst Stimulation for Episodic Memory Improvement in Mild Cognitive Impairment

Official Title

Network-targeted Theta-burst Stimulation for Episodic Memory Improvement in Mild Cognitive Impairment

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 26, 2021 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to see if stimulation of the brain can improve memory. The investigators will use a device called transcranial magnetic stimulation that can stimulate and activate a specific part of the brain that is important for memory. The study will enroll MCI subjects who will be randomly assigned to receive active or sham brain stimulation. 'Blinded' or 'sham-controlled' means that the subject will not know whether the treatment they receive is the active treatment or the non-active stimulation. In the 'sham' condition, the stimulator will turn on but will not actually be stimulating the target brain region.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognitive Dysfunction, Memory Disorders in Old Age

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active TBS

Arm Type

Experimental

Arm Description

Theta burst stimulation (TBS) will be delivered at 100% of motor threshold (MT).

Arm Title

Sham TBS

Arm Type

Sham Comparator

Arm Description

Sham stimulation will be delivered at 0% of motor threshold (MT), with all other parameters matching the active TBS condition.

Intervention Type

Device

Intervention Name(s)

Active Theta Burst Stimulation

Intervention Description

Theta burst transcranial magnetic stimulation (TBS) will be delivered at 80% of motor threshold (MT).

Intervention Type

Device

Intervention Name(s)

Sham Theta Burst Stimulation

Intervention Description

Sham stimulation will be delivered at 10% of motor threshold (MT), with all other parameters matching the active TBS condition.

Primary Outcome Measure Information:

Title

Verbal recall performance change

Description

Time Frame

Baseline: Day 2; During stimulation: Day 3, Day 7, Day 12, Day 17; Follow-up appointments: Day 18, Day 19, Day 20.

Title

Object recognition memory performance change

Description

Time Frame

Baseline: Day 2; During stimulation: Day 3, Day 7, Day 12, Day 17; Follow-up appointments: Day 18, Day 19, Day 20.

Title

Associative memory performance change

Description

Time Frame

Baseline: Day 2; During stimulation: Day 3, Day 7, Day 12, Day 17; Follow-up appointments: Day 18, Day 19, Day 20.

Secondary Outcome Measure Information:

Title

Resting state fMRI functional connectivity

Description

Resting state fMRI activity will be measured before the first and after the last TBS treatment

Time Frame

Baseline (Day 2) before the first treatment and after the last treatment (Day 17)

Title

EEG activity

Description

Time Frame

During treatment (Days 3, 7 and 12), and after the last treatment (Day 17)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Agreement to participate in the study 55-100 years of age Right-handedness In good general health Living independently Subjective memory complaints (self-report and positive score on MFQ) Katz ADL scale and Lawton iADL scale: We will review scores on a case-by-case basis if they did not score 100%. We will exclude if the scores show impairment in ADLs that suggests problems with independent functioning due to cognitive impairment. MMSE score > 24 PHQ Depression score =< 7 Ability to read, write, and speak English fluently Diagnosis of mild neurocognitive disorder according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria No change in use of psychotropic medication for treatment of depression, anxiety, ADHS or psychosis 1 month prior and during the study. Screening diagnostic criteria for aMCI will be subjective memory complaints, intact instrumental and basic activities of daily living (Smith et al., 1996), PHQ, MMSE, BVMT-R (25-minute delay), CVLT-II (20-minute delay), Rey-Osterrieth Complex Figure Task (30-minute delay). Baseline assessments will include neuropsychological testing of all study subjects. Exclusion Criteria: Unwilling or unable to provide informed consent Diagnosis of dementia Active major medical, psychiatric, or neurologic disorder associated with neurocognitive impairment History of alcohol or substance abuse Recent (< 6 months) alcohol or substance abuse (excluding nicotine or caffeine) History of stroke (if the stroke in our judgment is related to the memory problem), traumatic brain injury with loss of consciousness, or other neurologic disorder (e.g., epilepsy, Huntington's disease, Parkinson's disease) Non-English speaking participants Not right handed based on self-report or evaluation based on a standard report Has received TMS before (not TMS naïve) Poorly controlled hypertension or cardiovascular disease Current enrollment in a memory-enhancement study or course Contraindication to TMS or MRI including claustrophobia, metal in body, surgery within 60 days, certain implants, or previous abnormal MRI results. scanning facial tattoos is okay if safe with MRI is taking: anticholinergic medication (e.g., Detrol, Cogentin); sedating antihistamine (e.g., Benadryl); any drug that has significant anticholinergic or antihistaminic side effects (e.g., tricyclic antidepressant medications, Remeron). benzodiazepines. While not a strict rule out, this will be decided on a case-by-case basis depending on the dose.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sonja Hiller

Phone

310-210-6978

suthanalab@mednet.ucla.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nanthia Suthana

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90024

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sonja Hiller

Phone

310-210-6978

shiller@mednet.ucla.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The data collected for this research represent a valuable resource to the scientific community, and the PIs will make them accessible to others, while respecting the special needs for confidentiality. All data will be anonymized before being provided to the scientific community. Researchers can also request access to the data under collaborative and co-authorship agreements prior to the end of the funding period or before publication. The results from the proposed project will also be shared at scientific meetings (local, national and international) as well via published manuscripts.

IPD Sharing Time Frame

All data will be provided by the time publication occurs or when the proposed funding period has ended.

IPD Sharing Access Criteria

Researchers can request access to the data under collaborative and co-authorship agreements prior to the end of the funding period or before publication.

Learn more about this trial

Network-targeted Theta-burst Stimulation for Episodic Memory Improvement in Mild Cognitive Impairment

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