Trial Outcomes & Findings for TMS for Post Stroke Depression (NCT NCT04093843)

NCT ID: NCT04093843

Last Updated: 2022-04-29

Results Overview

Count of Adverse Events Reported during follow up

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: After Day 1 of rTMS treatment
• Results posted on: 2022-04-29

Participant Flow

Participant milestones

Measure	TMS: NeuroStar TMS Therapy Open label single arm study to determine safety and effectiveness of TMS for post stroke depression TMS: NeuroStar TMS Therapy
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Open Label n=6 Participants Open label single arm study to determine safety and effectiveness of TMS for post stroke depression TMS: NeuroStar TMS Therapy
Age, Continuous	66.33 years STANDARD_DEVIATION 4.97 • n=6 Participants
Sex: Female, Male Female	1 Participants n=6 Participants
Sex: Female, Male Male	5 Participants n=6 Participants

PRIMARY outcome

Timeframe: After Day 1 of rTMS treatment

Count of Adverse Events Reported during follow up

Outcome measures

Measure	Open Label n=6 Participants Open label single arm study to determine safety and effectiveness of TMS for post stroke depression TMS: NeuroStar TMS Therapy
Number of Participants With Adverse Events	0 Participants

PRIMARY outcome

Timeframe: After Day 2 of rTMS treatment

Count of Adverse Events Reported during follow up

Outcome measures

Measure	Open Label n=6 Participants Open label single arm study to determine safety and effectiveness of TMS for post stroke depression TMS: NeuroStar TMS Therapy
Number of Participants With Adverse Events	0 Participants

PRIMARY outcome

Timeframe: After Day 3 of rTMS treatment

Count of Adverse Events Reported during follow up

Outcome measures

Measure	Open Label n=6 Participants Open label single arm study to determine safety and effectiveness of TMS for post stroke depression TMS: NeuroStar TMS Therapy
Number of Participants With Adverse Events	0 Participants

PRIMARY outcome

Timeframe: After Day 4 of rTMS treatment

Count of Adverse Events Reported during follow up

Outcome measures

Measure	Open Label n=6 Participants Open label single arm study to determine safety and effectiveness of TMS for post stroke depression TMS: NeuroStar TMS Therapy
Number of Participants With Adverse Events	0 Participants

PRIMARY outcome

Timeframe: 3 months following neurostimulation

Count of Adverse Events Reported during follow up

Outcome measures

Measure	Open Label n=6 Participants Open label single arm study to determine safety and effectiveness of TMS for post stroke depression TMS: NeuroStar TMS Therapy
Number of Participants With Adverse Events	0 Participants

PRIMARY outcome

Timeframe: 6 months following neurostimulation

Count of Adverse Events Reported during follow up

Outcome measures

Measure	Open Label n=6 Participants Open label single arm study to determine safety and effectiveness of TMS for post stroke depression TMS: NeuroStar TMS Therapy
Number of Participants With Adverse Events	0 Participants

PRIMARY outcome

Timeframe: 12 months following neurostimulation

Count of Adverse Events Reported during follow up

Outcome measures

Measure	Open Label n=6 Participants Open label single arm study to determine safety and effectiveness of TMS for post stroke depression TMS: NeuroStar TMS Therapy
Number of Participants With Adverse Events	0 Participants

PRIMARY outcome

Timeframe: Depressive symptoms will be quantified before the rTMS stimulation protocol

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)

Outcome measures

Measure	Open Label n=6 Participants Open label single arm study to determine safety and effectiveness of TMS for post stroke depression TMS: NeuroStar TMS Therapy
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale	15.50 score on a scale Standard Deviation 2.81

PRIMARY outcome

Timeframe: Depressive symptoms will be quantified immediately after the 4 days of rTMS stimulation.

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)

Outcome measures

Measure	Open Label n=6 Participants Open label single arm study to determine safety and effectiveness of TMS for post stroke depression TMS: NeuroStar TMS Therapy
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale	4.17 score on a scale Standard Deviation 0.98

PRIMARY outcome

Timeframe: Depressive symptoms will be quantified 3 months after completion of the rTMS stimulation protocol.

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)

Outcome measures

Measure	Open Label n=6 Participants Open label single arm study to determine safety and effectiveness of TMS for post stroke depression TMS: NeuroStar TMS Therapy
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale	3.50 score on a scale Standard Deviation 2.66

PRIMARY outcome

Timeframe: Depressive symptoms will be quantified 6 months after completion of the rTMS stimulation protocol.

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)

Outcome measures

Measure	Open Label n=6 Participants Open label single arm study to determine safety and effectiveness of TMS for post stroke depression TMS: NeuroStar TMS Therapy
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale	5 score on a scale Standard Deviation 3.05

PRIMARY outcome

Timeframe: Depressive symptoms will be quantified 12 months after completion of the rTMS stimulation protocol.

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)

Outcome measures

Measure	Open Label n=6 Participants Open label single arm study to determine safety and effectiveness of TMS for post stroke depression TMS: NeuroStar TMS Therapy
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale	4.667 score on a scale Standard Deviation 5.022

Adverse Events

Open Label

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amelia Adcock, MD

West Virginia University

Phone: 304-598-6127

Email: akadcock@hsc.wvu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place