Stroke Clinical Trial
— STROKEBOSSOfficial 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
Verified date | July 2021 |
Source | University Hospital Tuebingen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | August 31, 2022 |
Est. primary completion date | August 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. Patients are between 18 to 85 years old 2. Patient suffers from chronic stroke including hand/arm paresis and spasticity 3. Ipsilesional motor evoked potentials (MEPs) can be evoked (EMG > 50uV) 4. RMT of contralesional side < 70% maximum stimulator output (MSO) 5. Patient is willing to comply with the study restrictions. 6. Subject FMA-UE at the lesioned side is <= 60. Exclusion Criteria 1. Patient is under the age of legal consent. 2. Patient has a history of seizure disorder. 3. 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). 4. Subject with intake of muscle-relaxing medication (e.g. baclofen, tizanidine, gabapentin,tolperisone, THC and derivates) 5. When spasticity is treated with botox there have to be at least tree months since the last injection 6. 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. 7. 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. 8. Patient has participated in another study within 2 weeks prior to the first study visit. 9. Patient is pregnant or trying to get pregnant. 10. Patient is unable to give informed consent. 11. Patient is unable to understand the instructions of the FMA-UE or not motivated to follow these instructions. 12. Patients who have contractions and therefore can't move. |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Tübingen, Department for Neurology and Stroke | Tübingen | Baden-Württemberg |
Lead Sponsor | Collaborator |
---|---|
University Hospital Tuebingen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Fugl-Meyer Assessment Upper Extremity (FMA-UE) | Upper limb, affected side | Difference of score directly before intervention and score directly after intervention | |
Primary | Change in Fugl-Meyer Assessment Upper Extremity (FMA-UE) | Upper limb, affected side | Difference of score directly before intervention and score 3 months after intervention | |
Secondary | Change in Wolf-Motor Function Test | Upper limb, affected side | Difference of score directly before intervention and score directly after intervention | |
Secondary | Change in Modified Ashworth Scale | Upper limb, affected side | Difference of score directly before intervention and score directly after intervention | |
Secondary | Change in PSAD spasticity assessment device score | Upper limb, affected side | Difference of score directly before intervention and score directly after intervention | |
Secondary | Change in Resting-motor-threshold (RMT) | Hand knob, affected hemisphere | Difference of score directly before intervention and score directly after intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Recruiting |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Active, not recruiting |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Recruiting |
NCT05993221 -
Deconstructing Post Stroke Hemiparesis
|