Theta Burst Stimulation for Motor Recovery
Study Details
Study Description
Brief Summary
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. This study will compare efficacy of different doses iTBS in combination with inhibitory rTMS on motor recovery and cortical excitability in subacute stroke patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology.
High and low frequencies of rTMS could modulate the excitability of the cerebral cortex. Theta burst stimulation (TBS) has achieved a similar effect to traditional rTMS mode. Intermittent TBS (iTBS) could upregulate cortical excitability of the primary motor cortex (M1) and continuous TBS (cTBS) with inhibitory effect. Through modulating the excitability of bilateral hemispheres, rTMS could facilitate motor recovery in stroke patients.
This study will compare efficacy of different doses iTBS in combination with inhibitory rTMS on motor recovery and cortical excitability in subacute stroke patients.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: contralateral 1Hz+ipsilateral iTBS 1 Patients received contralateral 1 Hz and ipsilateral iTBS with protocol 1 |
Device: repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. High and low frequencies of rTMS could modulate the excitability of the cerebral cortex. Theta burst stimulation (TBS) has achieved a similar effect to traditional rTMS mode. Intermittent TBS (iTBS) could upregulate cortical excitability of the primary motor cortex (M1) and continuous TBS (cTBS) with inhibitory effect.
|
| Experimental: contralateral 1Hz+ipsilateral iTBS 2 Patients received contralateral 1 Hz and ipsilateral iTBS with protocol 2 |
Device: repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. High and low frequencies of rTMS could modulate the excitability of the cerebral cortex. Theta burst stimulation (TBS) has achieved a similar effect to traditional rTMS mode. Intermittent TBS (iTBS) could upregulate cortical excitability of the primary motor cortex (M1) and continuous TBS (cTBS) with inhibitory effect.
|
| Active Comparator: contralateral 1Hz Patients received contralateral 1 Hz and ipsilateral sham iTBS |
Device: repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. High and low frequencies of rTMS could modulate the excitability of the cerebral cortex. Theta burst stimulation (TBS) has achieved a similar effect to traditional rTMS mode. Intermittent TBS (iTBS) could upregulate cortical excitability of the primary motor cortex (M1) and continuous TBS (cTBS) with inhibitory effect.
|
Outcome Measures
Primary Outcome Measures
- Fugl-Meyer Assessment [12 weeks post intervention]
Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.
Secondary Outcome Measures
- Medical Research Council (MRC) Scale for Muscle Strength [1 week, 4 weeks, 12 weeks and 24 weeks post intervention]
Medical Research Council (MRC) Scale for Muscle Strength, assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction).
- National Institutes of Health Stroke Scale [1 week, 4 weeks, 12 weeks and 24 weeks post intervention]
National Institutes of Health Stroke Scale, The maximum possible score is 42, with the minimum score being a 0. Higher scores indicate a worse outcome.
- Barthel Index [1 week, 4 weeks, 12 weeks and 24 weeks post intervention]
Barthel Index, score 100-0. Higher scores indicate a better outcome.
- Modified Rankin Scale [1 week, 4 weeks, 12 weeks and 24 weeks post intervention]
Modified Rankin Scale, score from 0 to 6. Higher scores indicate a worse outcome.
- MEP [1 week, 4 weeks, 12 weeks and 24 weeks post intervention]
motor evoked potential
- Fugl-Meyer Assessment [1 week post intervention]
Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.
- Fugl-Meyer Assessment [4 weeks post intervention]
Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.
- Fugl-Meyer Assessment [24 weeks post intervention]
Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
1.Unilateral ischemic or hemorrhagic stroke
-
2.Stroke within 3 months
-
3.Medical Research Council Scale for Muscle Strength in upper limb ≤ 3
-
4.No previous stroke, seizure, dementia, Parkinson's disease or other degenerative neurological diseases.
-
5.Patient could sit over 15 minutes
-
6.Age over 20
Exclusion Criteria:
-
1.Previous stroke, traumatic brain injury, brain tumor
-
2.With central nervous system disease (spinal cord injury, Parkinson's disease)
-
3.Any contraindication to rTMS (seizure, alcoholism, metal implant, pacemaker)
-
4.Patients unable to cooperate the treatment
-
5.Pregnancy
-
6.Depression
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Taiwan University Hospital | Taipei | Taiwan | 100 |
Sponsors and Collaborators
- National Taiwan University Hospital
Investigators
- Principal Investigator: Meng Ting Lin, M.D., The Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 202204105DINB