Back to resultsTMS for Post Stroke Depression
Primary Purpose
Post-stroke Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TMS
Sponsored by
About this trial
This is an interventional treatment trial for Post-stroke Depression
Eligibility Criteria
Inclusion Criteria:
- Between the ages of 22-85 years old
- Radiographic evidence of acute or subacute stroke
- Ischemic stroke diagnosed within the last 2 weeks to 6 months
- HAMD depression score 8 or greater
- Able to provide written informed consent
- Agree to participate in all study procedures
Exclusion Criteria:
- Metallic objects or neurostimulators implanted intracranially
- Stroke in the area of stimulation
- Current thoughts of SI or self-harm as assessed by the M.I.N.I. Suicide Scale score > 8
- ASRM (Altman Self Rating Mania Scale) score > 6 (6 or above indicates likelihood of manic symptoms)
- Current use of illicit substances
- Known history of epilepsy or seizure disorder
- Clinically significant EKG abnormalities including QTC prolongation >450 ms in men or >480 ms in women
Sites / Locations
- West Virginia University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TMS
Arm Description
Open label single arm study to determine safety and effectiveness of TMS for post stroke depression
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
Count of Adverse Events Reported during follow up
Number of Participants With Adverse Events
Count of Adverse Events Reported during follow up
Number of Participants With Adverse Events
Count of Adverse Events Reported during follow up
Number of Participants With Adverse Events
Count of Adverse Events Reported during follow up
Number of Participants With Adverse Events
Count of Adverse Events Reported during follow up
Number of Participants With Adverse Events
Count of Adverse Events Reported during follow up
Number of Participants With Adverse Events
Count of Adverse Events Reported during follow up
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04093843
Brief Title
TMS for Post Stroke Depression
Official Title
Accelerated rTMS as a Treatment for Post-stroke Depression in the Subacute Phase: an Open Label Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 24, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amelia Adcock
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to find alternative treatments for patient's suffering from depression after having a stroke.This study aims to show that accelerated rTMS is a safe, effective,and convenient treatment for patient's suffering from post-stroke depression in the acute to subacute phase. This will be an open label trial and thus all participants will receive the active rTMS intervention.
Detailed Description
The primary objectives of this project are as follows:
To assess the efficacy TMS in PSD. We hypothesize that there will be a decrease in the HAMD score in patients receiving TMS
To assess the feasibility of an accelerated protocol using rTMS in patients with acute to subacute stroke and co-existing PSD. We hypothesize that the accelerated protocol will promote compliance in our patient population and that the administration of this intervention is feasible.
To assess the safety of rTMS in patients with acute to subacute stroke. We hypothesize that the side effects of TMS will be minimal and the therapy will be well-tolerated and safe in individuals with recent strokes and co-existing PSD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open label
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TMS
Arm Type
Experimental
Arm Description
Open label single arm study to determine safety and effectiveness of TMS for post stroke depression
Intervention Type
Device
Intervention Name(s)
TMS
Intervention Description
NeuroStar TMS Therapy
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
Count of Adverse Events Reported during follow up
Time Frame
After Day 1 of rTMS treatment
Title
Number of Participants With Adverse Events
Description
Count of Adverse Events Reported during follow up
Time Frame
After Day 2 of rTMS treatment
Title
Number of Participants With Adverse Events
Description
Count of Adverse Events Reported during follow up
Time Frame
After Day 3 of rTMS treatment
Title
Number of Participants With Adverse Events
Description
Count of Adverse Events Reported during follow up
Time Frame
After Day 4 of rTMS treatment
Title
Number of Participants With Adverse Events
Description
Count of Adverse Events Reported during follow up
Time Frame
3 months following neurostimulation
Title
Number of Participants With Adverse Events
Description
Count of Adverse Events Reported during follow up
Time Frame
6 months following neurostimulation
Title
Number of Participants With Adverse Events
Description
Count of Adverse Events Reported during follow up
Time Frame
12 months following neurostimulation
Title
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
Description
Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
Time Frame
Depressive symptoms will be quantified before the rTMS stimulation protocol
Title
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
Description
Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
Time Frame
Depressive symptoms will be quantified immediately after the 4 days of rTMS stimulation.
Title
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
Description
Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
Time Frame
Depressive symptoms will be quantified 3 months after completion of the rTMS stimulation protocol.
Title
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
Description
Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
Time Frame
Depressive symptoms will be quantified 6 months after completion of the rTMS stimulation protocol.
Title
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
Description
Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
Time Frame
Depressive symptoms will be quantified 12 months after completion of the rTMS stimulation protocol.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between the ages of 22-85 years old
Radiographic evidence of acute or subacute stroke
Ischemic stroke diagnosed within the last 2 weeks to 6 months
HAMD depression score 8 or greater
Able to provide written informed consent
Agree to participate in all study procedures
Exclusion Criteria:
Metallic objects or neurostimulators implanted intracranially
Stroke in the area of stimulation
Current thoughts of SI or self-harm as assessed by the M.I.N.I. Suicide Scale score > 8
ASRM (Altman Self Rating Mania Scale) score > 6 (6 or above indicates likelihood of manic symptoms)
Current use of illicit substances
Known history of epilepsy or seizure disorder
Clinically significant EKG abnormalities including QTC prolongation >450 ms in men or >480 ms in women
Facility Information:
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32849235
Citation
Frey J, Najib U, Lilly C, Adcock A. Novel TMS for Stroke and Depression (NoTSAD): Accelerated Repetitive Transcranial Magnetic Stimulation as a Safe and Effective Treatment for Post-stroke Depression. Front Neurol. 2020 Aug 11;11:788. doi: 10.3389/fneur.2020.00788. eCollection 2020.
Results Reference
derived
Learn more about this trial
TMS for Post Stroke Depression
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