NCT04093843

TMS for Post Stroke Depression

Completed NA Results posted Last updated 29 April 2022

What this trial tests

NA trial testing TMS in Post-stroke Depression in 6 participants. Completed in 30 June 2020.

Timeline

24 October 2018

Primary endpoint
30 June 2020

30 June 2020

Quick facts

Lead sponsor	Amelia Adcock
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	24 October 2018
Primary completion	30 June 2020
Estimated completion	30 June 2020
Sites	1 location across United States

Drugs / interventions tested

• TMS — full drug profile →

Conditions studied

• Post-stroke Depression — all drugs for Post-stroke Depression →

Sponsor

Amelia Adcock

Who can join

Adults 22 to 85, any sex, with Post-stroke Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events Primary · After Day 1 of rTMS treatment

Count of Adverse Events Reported during follow up

Group	Value	95% CI
Open Label	0

Number of Participants With Adverse Events Primary · After Day 2 of rTMS treatment

Count of Adverse Events Reported during follow up

Group	Value	95% CI
Open Label	0

Number of Participants With Adverse Events Primary · After Day 3 of rTMS treatment

Count of Adverse Events Reported during follow up

Group	Value	95% CI
Open Label	0

Number of Participants With Adverse Events Primary · After Day 4 of rTMS treatment

Count of Adverse Events Reported during follow up

Group	Value	95% CI
Open Label	0

Number of Participants With Adverse Events Primary · 3 months following neurostimulation

Count of Adverse Events Reported during follow up

Group	Value	95% CI
Open Label	0

Number of Participants With Adverse Events Primary · 6 months following neurostimulation

Count of Adverse Events Reported during follow up

Group	Value	95% CI
Open Label	0

Number of Participants With Adverse Events Primary · 12 months following neurostimulation

Count of Adverse Events Reported during follow up

Group	Value	95% CI
Open Label	0

Depressive Symptoms as Rated by the Hamilton Depression Rating Scale Primary · 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)

Group	Value	95% CI
Open Label	15.50	± 2.81

Depressive Symptoms as Rated by the Hamilton Depression Rating Scale Primary · 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)

Group	Value	95% CI
Open Label	4.17	± 0.98

Depressive Symptoms as Rated by the Hamilton Depression Rating Scale Primary · 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)

Group	Value	95% CI
Open Label	3.50	± 2.66

Depressive Symptoms as Rated by the Hamilton Depression Rating Scale Primary · 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)

Group	Value	95% CI
Open Label	5	± 3.05

Depressive Symptoms as Rated by the Hamilton Depression Rating Scale Primary · 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)

Group	Value	95% CI
Open Label	4.667	± 5.022

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Novel TMS for Stroke and Depression (NoTSAD): Accelerated Repetitive Transcranial Magnetic Stimulation as a Safe and Effective Treatment for Post-stroke Depression.
   Frey J, Najib U, Lilly C, Adcock A. · · 2020 · cited 30× · PMID 32849235 · DOI 10.3389/fneur.2020.00788