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Stroke Therapy With Brain Oscillation Synchronized Stimulation (STROKEBOSS)

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Negative peak triggered 100 Hz triplet burst TMS

1 Hz rTMS

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients are between 18 to 85 years old
Patient suffers from chronic stroke including hand/arm paresis and spasticity
Ipsilesional motor evoked potentials (MEPs) can be evoked (EMG > 50uV)
RMT of contralesional side < 70% maximum stimulator output (MSO)
Patient is willing to comply with the study restrictions.
Subject FMA-UE at the lesioned side is <= 60.

Exclusion Criteria

Patient is under the age of legal consent.
Patient has a history of seizure disorder.
Patient with intake of pro-convulsive medication, e.g. , chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, MDMA (ecstasy), phencyclidine (PCP, angel's dust), ketamine, gamma-hydroxybutyrate (GHB), alcohol, theophylline, in accord with present consensus guidelines on safety, ethical considerations, and application of TMS in clinical practice and research (Rossi et al., 2009, 2021).
Subject with intake of muscle-relaxing medication (e.g. baclofen, tizanidine, gabapentin,tolperisone, THC and derivates)
When spasticity is treated with botox there have to be at least tree months since the last injection
Patient has a cardiac pacemaker, implanted medication pump, intracardiac line, that is located close to (≤ 10 cm) to the location of activation of the TMS coil or acute, unstable cardiac disease.
Patient has an intracranial implant (e.g., aneurysm clips, shunts, stimula-tors, cochlear implants, or electrodes) or any other metal object that is located close to (≤ 10 cm) to the location of activation of the TMS coil (excluding the mouth) and that cannot be safely removed.
Patient has participated in another study within 2 weeks prior to the first study visit.
Patient is pregnant or trying to get pregnant.
Patient is unable to give informed consent.
Patient is unable to understand the instructions of the FMA-UE or not motivated to follow these instructions.
Patients who have contractions and therefore can't move.

Sites / Locations

University Hospital Tübingen, Department for Neurology and Stroke

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

µ-alpha oscillation coupled ipsilesional 100 Hz triplet bursts

contralesional 1 Hz rTMS

Arm Description

µ-rhythm (The µ rhythm frequency band is defined by activity falling between 8 and 13 Hz and recorded by scalp electrodes over the sensorimotor cortex during waking neural activity) negative peak triggered TMS of ipsilesional primary motor cortex, consisting of 400 triple pulses at 100 Hz, delivered at a mean inter-triple pulse interval of 3.0 s. Stimulation intensity: 100% resting motor threshold.

1200 stimuli to the contralesional primary motor cortex at 1 Hz. Stimulation intensity: 115% resting motor threshold.

Outcomes

Primary Outcome Measures

Change in Fugl-Meyer Assessment Upper Extremity (FMA-UE)

Upper limb, affected side

Change in Fugl-Meyer Assessment Upper Extremity (FMA-UE)

Upper limb, affected side

Secondary Outcome Measures

Change in Wolf-Motor Function Test

Upper limb, affected side

Change in Modified Ashworth Scale

Upper limb, affected side

Change in PSAD spasticity assessment device score

Upper limb, affected side

Change in Resting-motor-threshold (RMT)

Hand knob, affected hemisphere

Full Information

NCT ID

NCT05005780

First Posted

July 21, 2021

Last Updated

August 16, 2023

Sponsor

University Hospital Tuebingen

1. Study Identification

Unique Protocol Identification Number

NCT05005780

Brief Title

Stroke Therapy With Brain Oscillation Synchronized Stimulation

Acronym

STROKEBOSS

Official Title

Stroke Therapy With Brain Oscillation Synchronized Stimulation: Randomized Controlled Pilot Study to Compare the Therapeutic Effectiveness of a Personalized EEG-triggered Repetitive High-frequency TMS Therapy Protocol With Standard Low-frequency TMS Therapy Protocol in Patients With Spastic Paresis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

October 2, 2019 (Actual)

Primary Completion Date

August 31, 2022 (Actual)

Study Completion Date

August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital Tuebingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This randomized, controlled, double-blind clinical pilot trial investigates the therapeutic potential of a novel personalized therapeutic brain-stimulation protocol in chronic stroke patients with spasticity. Stroke patients will either receive ipsilesional 100 Hz transcranial magnetic stimulation (TMS) triplet burst protocol synchronized to the ongoing µ-alpha oscillation or contralesional 1 Hz repetitive TMS (rTMS) protocol. Motor recovery is assessed directly after as well as three months after completion of the therapy.

Detailed Description

Stroke is one of the leading cause for long-term disability worldwide. The standard approach to treat deficits after stroke is a rehabilitation therapy, that follows the stroke event directly. This therapy mainly includes physiotherapy and occupational therapy. Yet, despite intensive rehabilitation efforts, more than half of all stroke patients remain greatly disabled. Repetitive TMS is capable of inducing plasticity-like effects in the brain, that are expected to enhance adaptive plasticity processes leading to functional regain after stroke. In the motor cortex, brain oscillation-synchronized TMS, i.e. TMS triggered dependent on the phase of instantaneous µ-alpha oscillations as detected by real-time EEG (electroencephalography) analysis, has been shown to consistently increase motor cortical excitability and plasticity effects. We therefore hypothesis that a greater therapeutic potential of TMS to modulate dysfunctional brain networks can be exploited by personalizing TMS therapy to individual brain states (i.e. brain oscillations). This study aims to investigate the effectiveness of an ipsilesional 100 Hz TMS triplet burst protocol synchronized to the ongoing µ-alpha oscillation compared to the current TMS standard therapy of contralesional 1 Hz rTMS in chronic stroke patients. Both groups will undergo stimulation therapy three times a week, with each session directly followed by physiotherapy. Motor recovery will be assessed directly after as well as three months after completion of the therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

µ-alpha oscillation coupled ipsilesional 100 Hz triplet bursts

Arm Type

Experimental

Arm Description

Arm Title

contralesional 1 Hz rTMS

Arm Type

Active Comparator

Arm Description

1200 stimuli to the contralesional primary motor cortex at 1 Hz. Stimulation intensity: 115% resting motor threshold.

Intervention Type

Device

Intervention Name(s)

Negative peak triggered 100 Hz triplet burst TMS

Intervention Description

MagVenture MagPro X100: Ipsilesional negative peak triggered 100 Hz triplet burst TMS.

Intervention Type

Device

Intervention Name(s)

1 Hz rTMS

Intervention Description

MagVenture MagPro X100: Contralesional 1 Hz rTMS.

Primary Outcome Measure Information:

Title

Change in Fugl-Meyer Assessment Upper Extremity (FMA-UE)

Description

Upper limb, affected side

Time Frame

Difference of score directly before intervention and score directly after intervention

Title

Change in Fugl-Meyer Assessment Upper Extremity (FMA-UE)

Description

Upper limb, affected side

Time Frame

Difference of score directly before intervention and score 3 months after intervention

Secondary Outcome Measure Information:

Title

Change in Wolf-Motor Function Test

Description

Upper limb, affected side

Time Frame

Difference of score directly before intervention and score directly after intervention

Title

Change in Modified Ashworth Scale

Description

Upper limb, affected side

Time Frame

Difference of score directly before intervention and score directly after intervention

Title

Change in PSAD spasticity assessment device score

Description

Upper limb, affected side

Time Frame

Difference of score directly before intervention and score directly after intervention

Title

Change in Resting-motor-threshold (RMT)

Description

Hand knob, affected hemisphere

Time Frame

Difference of score directly before intervention and score directly after intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients are between 18 to 85 years old Patient suffers from chronic stroke including hand/arm paresis and spasticity Ipsilesional motor evoked potentials (MEPs) can be evoked (EMG > 50uV) RMT of contralesional side < 70% maximum stimulator output (MSO) Patient is willing to comply with the study restrictions. Subject FMA-UE at the lesioned side is <= 60. Exclusion Criteria Patient is under the age of legal consent. Patient has a history of seizure disorder. Patient with intake of pro-convulsive medication, e.g. , chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, MDMA (ecstasy), phencyclidine (PCP, angel's dust), ketamine, gamma-hydroxybutyrate (GHB), alcohol, theophylline, in accord with present consensus guidelines on safety, ethical considerations, and application of TMS in clinical practice and research (Rossi et al., 2009, 2021). Subject with intake of muscle-relaxing medication (e.g. baclofen, tizanidine, gabapentin,tolperisone, THC and derivates) When spasticity is treated with botox there have to be at least tree months since the last injection Patient has a cardiac pacemaker, implanted medication pump, intracardiac line, that is located close to (≤ 10 cm) to the location of activation of the TMS coil or acute, unstable cardiac disease. Patient has an intracranial implant (e.g., aneurysm clips, shunts, stimula-tors, cochlear implants, or electrodes) or any other metal object that is located close to (≤ 10 cm) to the location of activation of the TMS coil (excluding the mouth) and that cannot be safely removed. Patient has participated in another study within 2 weeks prior to the first study visit. Patient is pregnant or trying to get pregnant. Patient is unable to give informed consent. Patient is unable to understand the instructions of the FMA-UE or not motivated to follow these instructions. Patients who have contractions and therefore can't move.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ulf Ziemann, Prof. Dr.

Organizational Affiliation

University Hospital Tübingen, Department of Neurology and Stroke

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Tübingen, Department for Neurology and Stroke

City

Tübingen

State/Province

Baden-Württemberg

ZIP/Postal Code

72076

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Stroke Therapy With Brain Oscillation Synchronized Stimulation

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