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

NCT03761303 | Withdrawn

• 1 other identifier: rTMS-PSD
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

rTMS; Escitalopram; add-on therapy

Outcome Measures

Primary Outcomes (1)

• Changes of Hamilton Depression Rating Scale [HAM-D; 17 Item Version]

  The primary endpoint is the change in the HAM-D score. A decrease of at least 50% from baseline on day 29 is considered clinically significant. From this, the responder rate is determined.

  For the clinical assessment of the severity of depression, the HAM-D is collected at the following times: day -7; baseline (day 1 before rTMS stimulation); day 2, day 8, day 15 and day 22).

Secondary Outcomes (2)

• HAM-D score ≤8 Points

  baseline (day 1 before rTMS stimulation); day 22

• HAM-D score (day -baseline)

  baseline (day 1 before rTMS stimulation); day 36

Study Arms (2)

active rTMS

ACTIVE COMPARATOR

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).

Device: active rTMS

sham rTMS

SHAM COMPARATOR

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

Device: sham rTMS

Interventions

active rTMS DEVICE

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.

active rTMS

sham rTMS DEVICE

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).

sham rTMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first insult
• Post-stroke Depression (17 item version of the Hamilton Depression Rating Scale \[HAM-D\]\> 18 points)
• capacity to consent

You may not qualify if:

• insufficient cardiorespiratory stability
• previous depression or previous use of antidepressants
• pre-stroke psychological illnesses (eg psychosis, bipolar disorder)
• severe cognitive impairment
• aphasia
• lefthanded
• decreased seizure threshold or history of epileptic seizures
• taking medicines that lower the seizure threshold (local anesthetics, cortisone, alcohol, neuroleptics)
• hemorrhages and cerebral edema (e.g., subarachnoid haemorrhage, intracerebral hemorrhage, subdural hematoma, epidural hematoma)
• fresh and healed head wounds near the area to be stimulated
• missing bone cover (relief spread)
• colonization with a germ requiring isolation (e.g., MRSA, 3MRGN, 4MRGN)
• recent myocardial infarction or higher grade cardiac arrhythmias
• contraindications to rTMS: Metallic or magnetic implants containing iron, cobalt or nickel (e.g., pacemakers, brain pacemakers, automatic insulin pumps, electrodes, plates, clips, implanted hearing aids, dental implants, metal endoprostheses, metal parts, or metal fragments in the body).
• pregnancy

Sponsors & Collaborators

• BDH-Klinik Hessisch Oldendorf: lead

Study Sites (1)

Institute for rehabilitative Research, BDH-Clinic Hessich Oldendorf

Hessisch Oldendorf, Lower Saxony, 31840, Germany

Location

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The randomization of the patients is carried out by a non-medical employee. This co-worker maintains a randomly generated randomization list, indicating to the particular study code (e.g., TMS-PSD-001; TMS-PSD-002), whether to perform an active or sham treatment. The employee pulls a number from an envelope before beginning the intervention of each enrolled patient and then looks at the list to identify the particular group assignment. There will always be randomization packages of ten patients each. Once these are used up, a new list and a new envelope with study codes are prepared. In addition, the "real" and the placebo coils are coded before starting studies (eg "A" and "B"). Only the uninvolved employee is the assignment to the real - or placebo coil known. The uninvolved employee randomly assigns the study code containing the information on which coil to use ("A" or "B"). In this way a blinding of performing physician, patient and the evaluating scientist is guaranteed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Researcher

Model Details: All patients will receive standard antidepressant therapy with 15 mg escitalopram (Selective Serotonin Reuptake Inhibitor) per day during the study. The dose of escitalopram is increased in all included patients from 5mg/day (day 1-3), over 10mg/day (day 4-6) to 15mg/day (from day 7). Patients in the experimental 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). The comparison group receives a duration of equal long sham-stimulation. For transcranial magnetic stimulation, the Stimulator "PowerMAG Research 100" (Mag \& More, Munich, Germany) is used with a cooled double coil (PMD70-pCool).

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 3, 2018
• Study Start: May 1, 2018
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2022
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)