Theta-Burst-Stimulation in Recurrent Stroke Recovery

Stroke Clinical Trial

Official title:

Theta-Burst-Stimulation in Recurrent Stroke Recovery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03337867
• Other study ID #: U1111-1204-6783
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 11, 2018
• Est. completion date: November 1, 2021

Study information

• Verified date: November 2019
• Source: University Hospital of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study aims at investigating the effects of intermittent theta-burst stimulation (iTBS) for motor recovery in recurrent stroke patients. Therefore a daily intervention of repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy is compared to a control condition, sham stimulation combined with subsequent physiotherapy. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.

Description:

To date, the majority of neuromodulation approaches aiming at improving motor recovery after stroke are limited to patients with first-ever ischemic stroke. Therefore, rehabilitation of recurrent stroke mainly includes physiotherapy and occupational therapy. Yet, particular these patients retain movement impairment relevant for activities of daily living.

By using repetitive transcranial magnetic stimulation (rTMS), it is possible to promote recovery of connectivity between brain regions, particularly after stroke and thereby improve motor performance. Previous data indicate that intermittent theta-burst stimulation (iTBS), a protocol of neuromodulation, enhances the effects of subsequent motor training in early rehabilitation after stroke.

The current study aims at investigating whether daily repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy leads to better motor recovery in recurrent stroke, compared to control condition, physiotherapy after sham stimulation. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• written consent

• age: 40-90 years

• recurrent stroke

• hemiparesis with impaired hand motor function

Exclusion Criteria:

• Subjects who are legally detained in an official institute (§20 MPG)

• Electronic implants or ferromagnetic Implants located in the head, neck or thorax (e.g. clips, intracranial shunt, artificial heart valve, pacemaker)

• Medication pump (e.g. insulin pump)

• Metal splinters in eye or head

• Pregnancy / breastfeeding

• Severe Neurodegenerative disease

• Severe Neuroinflammatory disease

• History of seizures / epilepsy

• Physical addiction to alcohol, medication, or drugs (excluded: nicotine)

• Insufficient compliance

• Present or past malignant tumor involving the central nervous system

• Severe Psychiatric disease

• Frequent medication with benzodiazepines, high-potency antipsychotics or tricyclic antidepressants before hospitalization or long-term during hospitalization

Related Conditions & MeSH terms

• Neurorehabilitation
• Stroke

Intervention

Device:
• Magstim Super Rapid2 System
Intermittent theta-burst-stimulation (iTBS) protocol
• Magstim Super Rapid2 System
Sham stimulation

Locations

Country	Name	City	State
Germany	Christian Grefkles	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative grip force	grip force as measured with vigorimeter	3 months after enrollment
Secondary	Relative grip force	Grip force as measured with vigorimeter	After 8 days of intervention, and 3 months of enrollment
Secondary	Motor function	Action Research Arm Test, ARAT	After 8 days of intervention, and 3 months of enrollment
Secondary	Motor function	Fugl-Meyer Motor Scale of the upper extremity, FM The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully.; Minimum score in upper limb = 0 Maximum score in upper limb = 66, Subscales are summed	After 8 days of intervention, and 3 months of enrollment
Secondary	Stroke severity	National Instituts of Health Stroke Scale, NIHSS The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.; The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.	After 8 days of intervention, and 3 months of enrollment
Secondary	Degree of disability	Modified Rankin Scale, mRS The scale runs from 0-6, running from perfect health (0) without symptoms to death (6).	After 8 days of intervention, and 3 months of enrollment
Secondary	Motor cortex excitability/ Motor evoked potential	Motor evoked potential (MEP) induced by stimulation of the affected motor cortex	After 8 days of intervention, and 3 months of enrollment
Secondary	Motor cortex excitability/ Resting motor threshold	Resting motor threshold as measured by stimulation of the affected motor cortex, RMT	After 8 days of intervention, and 3 months of enrollment
Secondary	Motor cortex excitability/ Short-interval intracortical inhibition	Short-interval intracortical inhibition Short-interval intracortical inhibition (SICI) is a widely used paired-pulse transcranial magnetic stimulation (TMS) measure to assess inhibition in human motor cortex	After 8 days of intervention, and 3 months of enrollment
Secondary	Motor cortex excitability/ Ipsilateral silent period	Ipsilateral silent period The ipsilateral silent period (iSP) is supposed to be a specific marker of transcallosal motor inhibition. Measured by a short attenuation or interruption of ongoing voluntary electromyographic (EMG) activity in hand muscles induced by focal TMS of the ipsilateral M1.	After 8 days of intervention, and 3 months of enrollment
Secondary	Quality of life	EuroQol 5D questionnaire, EQ-5D	After 8 days of intervention, and 3 months of enrollment
Secondary	Activities of daily living at admission and discharge in external rehabilitation facility	Barthel-Index (BI) scores as documented by external rehabilitation facility The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL). A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. The scale yield a score of 0-100.	After 8 days of intervention, and 3 months of enrollment
Secondary	Days of rehabilitation after intervention phase	Days of rehabilitation after intervention phase as documented by external rehabilitation facility	3 months after enrollment