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Transmagnetic Stimulation Pilot in Primary Progressive Aphasia (TMS in PPA)

Primary Purpose

Primary Progressive Aphasia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intermittent theta burst stimulation
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Progressive Aphasia focused on measuring transmagnetic stimulation, functional MRI guided Theta Burst Stimulation

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Established diagnosis of NFV-PPA and SV-PPA based on criteria (Gorno-Tempini et al., 2011) Prior brain imaging performed Mini Mental Status Exam (MMSE)>10 Subjects are between 40-90 years of age Exclusion Criteria: Non-FTD dementia including, but not limited to Alzheimer's, disease, Lewy body dementia, frontotemporal dementia, vascular dementia, Jakob-Creutzfeldt disease, etc. Inability to tolerate rs-fMRI Contraindication of rs-fMRI due to implants or metal Seizure disorder

Sites / Locations

  • HealthPartners Neuroscience Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intermittent theta burst stimulation

Arm Description

All subjects will receive treatment with intermittent theta burst stimulation (iTBS). There will be a total of 5 treatments over a 2-week period. All subjects will receive iTBS to the right TGd region. TBS treatment will also be provided for two additional sites within the large-scale brain networks (LSBNs) that is found to contain the greatest number of connectivity anomalies. Total participation will be 8-10 weeks.

Outcomes

Primary Outcome Measures

Connectivity measures of the left TGd, 55b, and STV parcellations at baseline and post-treatment
The difference and corresponding 95% confidence interval between follow-up and baseline connectivity measures of the TGd parcellations. Range: -1 to 1. Positive values indicate areas where connectivity is higher than healthy controls from the Human Connectome Project.

Secondary Outcome Measures

Full Information

First Posted
May 5, 2023
Last Updated
October 6, 2023
Sponsor
HealthPartners Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05860647
Brief Title
Transmagnetic Stimulation Pilot in Primary Progressive Aphasia
Acronym
TMS in PPA
Official Title
A Single Arm Study of Resting State Functional Magnetic Resonance Imaging (Rs-fMRI)-Guided Theta Burst Stimulation (TBS) in Primary Progressive Aphasia (PPA)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 2, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Frontotemporal degeneration (FTD) is a non-Alzheimer's dementia that is the 2nd most common cause of dementia in the United States. FTD may present with focal language symptoms that are clinically described as primary progressive aphasia (PPA). There are two types of PPA associated with FTD-semantic variant primary progressive aphasia (SV-PPA) and nonfluent/agrammatic variant primary progressive aphasia (NFV-PPA). Both diseases are progressive neurodegenerative disease processes that compromise dominant hemisphere large scale brain network function, ultimately resulting in mutism. There are currently no FDA-approved treatments for PPA and management is mostly supportive. In combination with resting state functional MRI (rs-fMRI), transcranial magnetic stimulation (TMS) with intermittent theta burst stimulation (iTBS) offers a non-invasive alternative to pharmacotherapy in persons with PPA. In our prior studies of Alzheimer's disease (AD) and Lewy body Dementia (LBD) subjects, investigators have determined that the anterior temporal pole (area TGd and TGv) is an area that is commonly dysfunctional in dementia. The investigators have already embarked upon an fMRI guided study of iTBS in early stage Alzheimer's disease where subjects received a series of 5 treatments to distinct brain regions inclusive of area TGd. The investigators propose a case study of 3 PPA studies where rs-fMRI is applied to the large-scale language networks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Progressive Aphasia
Keywords
transmagnetic stimulation, functional MRI guided Theta Burst Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intermittent theta burst stimulation
Arm Type
Experimental
Arm Description
All subjects will receive treatment with intermittent theta burst stimulation (iTBS). There will be a total of 5 treatments over a 2-week period. All subjects will receive iTBS to the right TGd region. TBS treatment will also be provided for two additional sites within the large-scale brain networks (LSBNs) that is found to contain the greatest number of connectivity anomalies. Total participation will be 8-10 weeks.
Intervention Type
Device
Intervention Name(s)
Intermittent theta burst stimulation
Other Intervention Name(s)
Transmagnetic stimulation, MagVenture
Intervention Description
MagVenture TMS Therapy with theta burst stimulation. Resting motor threshold: 80%; Number of pulses per session: 1200 pulses; Inter-train interval: 8 seconds; Pulse frequency in burst: 50 Hertz
Primary Outcome Measure Information:
Title
Connectivity measures of the left TGd, 55b, and STV parcellations at baseline and post-treatment
Description
The difference and corresponding 95% confidence interval between follow-up and baseline connectivity measures of the TGd parcellations. Range: -1 to 1. Positive values indicate areas where connectivity is higher than healthy controls from the Human Connectome Project.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Established diagnosis of NFV-PPA and SV-PPA based on criteria (Gorno-Tempini et al., 2011) Prior brain imaging performed Mini Mental Status Exam (MMSE)>10 Subjects are between 40-90 years of age Exclusion Criteria: Non-FTD dementia including, but not limited to Alzheimer's, disease, Lewy body dementia, frontotemporal dementia, vascular dementia, Jakob-Creutzfeldt disease, etc. Inability to tolerate rs-fMRI Contraindication of rs-fMRI due to implants or metal Seizure disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael H Rosenbloom, MD
Organizational Affiliation
HealthPartners Neurology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kashyap Bhavani, PhD,MBBS
Organizational Affiliation
HealthPartners Neuroscience Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
HealthPartners Neuroscience Center
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55130
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Transmagnetic Stimulation Pilot in Primary Progressive Aphasia

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