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rTMS as an add-on Therapy in Patients With Post-stroke Depression

NCT03761303 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-12-17

No results posted yet for this study

Summary

About 50% of all stroke patients develop post-stroke depression (PSD). A meta-analysis has shown that rTMS treatment can reduce depressive symptoms in PSD patients. In addition to rTMS alone for the improvement of depression, the question arises as to whether a combination therapy of rTMS plus antidepressant medication can achieve a stronger or longer-term effect in PSD patients. Unfortunately, there are currently no trials of combination therapy with rTMS and drug therapy in PSD patients. Therefore, this study will investigate whether combination therapy of antidepressant and rTMS can provide additional relief of depressive symptoms compared to antidepressant and sham rTMS therapy. It is assumed that the additional active rTMS achieves a faster normalization of affect and drive than with a sham rTMS, so that the patients benefit from neurorehabilitation measures earlier and more sustainably.

Conditions

  • Post-stroke Depression

Interventions

DEVICE

active rTMS

The rTMS coil is applied tangentially to the head surface above the left DLPF (corresponding to position F3 of the international 10-20 system). For the stimulation intensity, the motor rest threshold of the patient is determined. The motor rest threshold is defined as the minimum intensity that triggers an EMG response with an amplitude\> 50 μV in the first right interosseus dorsalis muscle in at least 5 out of 10 cases. The stimulation intensity within the rTMS therapy is 80 percent of the motor rest threshold. In one session, 1,000 pulses are applied in 10 trains at a frequency of 10 Hz (1 train = 100 pulses in 10 s). Between the individual trains there is an inter-train interval of 28 seconds. The total duration of a session is 5:52 minutes. In total, the patient recieve 20 sessions.

DEVICE

sham rTMS

Patients in the intervetion group (active rTMS stimulation) receive active 10 Hz rTMS stimulation over the left dorsolateral prefrontal cortex (DLPFC) over a period of 20 days, seven days a week (20 sessions).

Sponsors & Collaborators

  • BDH-Klinik Hessisch Oldendorf

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2021-11-01
Completion
2022-11-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03761303 on ClinicalTrials.gov