StrokeNCT01847157
Transcranial Direct Current Stimulation Combined Sensory Modulation Intervention in Chronic Stroke Patients
A study testing tDCS, Epidermis anesthesia and Repeated passive movement in people with Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Background and purpose: About 30% of people with stroke suffered from severe long-term upper extremity （UE） motor impairment. Severe UE impairment, especially dysfunction of hand, can greatly impact stroke patients' daily living independence and quality of life. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- tDCS, Epidermis anesthesia and Repeated passive movement
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first ever ischemic or hemorrhagic stroke patients identified by computed tomography (CT) or magnetic resonance imaging (MRI)
- age between 40 and 80 years old
- have a stroke over 6 months
- unilateral hemiplegia
- Fugl-Meyer assessment-upper extremity (FMA-UE) score≦29 when selection
- poststroke elbow flexor spasticity less than 2 using modified Ashworth scale (MAS)
Show all 10Show fewer
- no severe anesthesia (FMA sensory test, upper extremity score≧10 )
- no wrist and finger joint pain
- clear consciousness, can understand simple sentences and spoken orders, and co-operate manipulation
- can accept motor training in the sitting position for approximately 30 minutes.
Who cannot join
- Suffer from other orthopedic diseases (such as severe arthritis), nerve damage (such as peripheral nerve damage), or severe pain, which influences upper extremity motor
- have a medical history or family history of epilepsy
- regularly take central nervous system drugs (such as sedatives), or the Class III antiarrhythmic drugs (such as amiodarone)
- have atopic dermatitis or skin disorders of the scalp
- have allergy to anesthetic medicines of the acyl amine
- have a metal implant in the head or neck, or serious arrhythmia (the heartbeat is less than 50 beats per minute or higher than 100 beats per minute); or use a pacemaker or atrial defibrillator
- suffer from congenital or idiopathic methemoglobinemia. Aphasia is not an exclusion criterion, but the patients should understand simple spoken orders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Transcranial Direct Current Stimulation Combined Sensory Modulation Intervention on Upper Extremity Functional Rehabilitation in Patients With Chronic Stroke
Background and purpose:
About 30% of people with stroke suffered from severe long-term upper extremity （UE） motor impairment. Severe UE impairment, especially dysfunction of hand, can greatly impact stroke patients' daily living independence and quality of life. However, treatment effect of current interventions is still limited. Nick Ward and Leonardo Cohen suggested 5 intervention strategies for stroke motor recovery: （1） reduction of somatosensory input from the intact; （2） increase in somatosensory input from the paretic; （3） anesthesia of a body part proximal to the paretic hand; （4） activity within the affected motor cortex may be up-regulated; （5） activity within the intact motor cortex may be down-regulated. Recent studies have shown each strategy to be effective in stroke patients with mild or moderate UE impairment. However, evidence for people with severe UE impairment after stroke remains unclear. Since research has found a greater effect for combined strategies than a single strategy, this proposal develops a combined intervention with the above 5 strategies, named "transcranial direct current stimulation （tDCS） combined sensory modulation intervention". This intervention is expected to be most effective for people with severe UE impairment after stroke.
Read more
In addition, neuroimaging can provide in vivo information about the brain plasticity which underpinning the motor recovery after stroke. However, image indexes that can be used in stroke patients with severe UE impairment remained examined. Therefore, this proposal has 3 aims: （1） to examine the treatment effect of the "tDCS combined sensory modulation intervention" in stroke patients with severe UE impairment; （2） to examine the underline mechanism of the efficacy of "tDCS combined sensory modulation intervention" using neuroimaging technology.
Methods:
This study is a double-blinded randomized controlled trial which will recruit 60 people who have had stroke onset more than 6 months and have severe UE motor impairment. All participants will be randomly assigned into 2 groups. The experimental group will be given the "tDCS combined sensory modulation intervention", combining bilateral tDCS stimulation, anesthesia techniques and repetitive passive motor training. The control group is given sham tDCS, sham anesthesia and repetitive passive motor training. Each group will be evaluated for outcomes at 4 time points （i.e. baseline, post-intervention, 3 months and 6months post-intervention）. The immediate and long-term effect of the interventions will be examined.
Primary outcome indicators include upper extremity impairment measures. Secondary outcome measures include upper extremity function, activities of daily living function, functional Magnetic Resonance Imaging （fMRI）, and corticospinal tract structural integrity using diffusion spectrum imaging （DSI）. Fifteen subjects of each group will be assessed 2 times （i.e., prior to the intervention and after the intervention） for fMRI and DSI scan.
Anticipatory results and contributions:
The results of the studies are expected to present a potentially effective intervention for stroke patients with severe impaired UE motor. Imaging evidence of brain plasticity for this particular intervention is also provided. The results will contribute to our understanding of brain plasticity for UE motor recovery after stroke. Findings from this proposal may help researchers and clinicians choose or develop interventions that are optimal to their clients individually.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called Intelect mobile combination
Intelect mobile combination (Intelect, USA) is utilized as a direct current stimulator. The 25 cm2 electrodes on a sponge slice immersed in physiological salt solution are fixed on the left and right positions C3/ C4 of subject head (according to the international 10-20 system of electroencephalogram).
During the treatment, 1.5 mA electric current is applied to stimulate the subjects in the experimental group for totally 30 minutes. At the start and the end of stimulation, the electric current will gradually increase from zero, or reduce to zero in 1 minute in order to avoid the possible appearance of slight flash effect of subject eyesight, which is caused by instantly turning on or turning off the electric current.
Epidermis anesthesiaDrug
Also called Emla 5% cream (Lignocaine 2.5% / Prilocaine 2.5%)
15 g of Emla 5% Cream(anesthetic) is applied to the ventral surface of the forearm of unaffected side with a distance of 10 mm from the wrist, and an area of 150 mm long x 50 mm wide.
Furthermore, 10 g Emla 5% Cream(anesthetic) is applied to the ventral surface of the upper arm of affected side with a distance of 10 mm from the wrist, and an area of 100 mm long x 50 mm wide.
sham anesthesiaDrug
Also called Cetaphil, body cream
15 g of 5% body Cream is applied to the ventral surface of the forearm of unaffected side with a distance of 10 mm from the wrist, and an area of 150 mm long x 50 mm wide.
10 g body Cream is applied to the ventral surface of the upper arm of affected side with a distance of 10 mm from the wrist, and an area of 100 mm long x 50 mm wide.
Repeated passive movementOther
Repeated passive wrist extension training: Patients' wrist joint are passively moved by a trained occupational therapist (joint moving angle = 0- 60 degree), frequency 1 Hz, maintain for 20 minutes.
Finger passive flexion and extension training: Patients' fingers joint are passively moved by a trained occupational therapist, frequency 1 Hz, maintain for 10 minutes.
sham tDCSDevice
Also called Intelect mobile combination
The equipment of sham stimulation in the control group is exactly the same as the equipment in the experiment group. However, the only difference is that 30 seconds after the start of electric current, the experimenter turns off the powder under subject ignorance situation. The stimulation just gives patients weak sense of electric current, in order to blind them for which group they are in.
| Study group | Role | What they receive |
|---|---|---|
| tDCS & epidermis anesthesia & repeated passive movement | Experimental | The patients in the experiment group will receive multi-strategy combination treatment mode- "combined tDCS and sensory input regulation treatment mode", including bilateral tDCS , epidermis anesthesia in the proximal hand of affected side and in the distal hand of unaffected side , and repeated passive movement training for the hand of affected side.
Treatment modes are 3 times a week, 30 minutes each time, lasting for 8 weeks, and totally 24 trainings. The treatment content of each strategy is separately described in the following. Receives: Device: tDCS; Drug: Epidermis anesthesia; Other: Repeated passive movement |
| Shame tDCS & sham anesthesia & repeated passive movement | Sham comparator | the control group is "repeated passive movement stimulation", including sham bilateral tDCS, sham epidermis anesthesia in the proximal hand of affected side and in the distal hand of unaffected side, and repeated passive movement training for the hand of affected side.
Treatment modes are 3 times a week, 30 minutes each time, lasting for 8 weeks, and totally 24 trainings. The treatment content of each strategy is separately described in the following. Receives: Drug: sham anesthesia; Other: Repeated passive movement; Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Fugl Meyer Assessment(FMA)upper extremities subscale after intervention
FMA-UE estimates the movement of proximal upper extremity (including shoulder joint, elbow joint and forearm), wrist joint and hand.
Each movement is estimated by 3 scaled rules (0-1-2): score 0 indicates that the patient has no movement at all; score 1 indicates that the patient can perform partial movements; score 2 indicates that the patient can normally perform all movements.
The total score in the differential scale is 66, and a higher score indicates that the patient has better movement ability.
Measured: Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)
Change from baseline Active joint activity after intervention
A protractor is used to estimate 4 active joint activities of patients,including wrist extension, carpometacarpal extension, metacarpophalangeal extension, and shoulder flexion.
Measured: Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)
Change from baseline Muscle tone after intervention
Motor assessment scale (MAS) is used to estimate muscle tension in patients, and the estimated muscles include the flexors and extensors of elbow, wrist and metacarpophalangeal joints.
MAS is totally divided into 6 scales (0, 1, 1+, 2, 3, 4), and a higher score indicates that the patient has higher muscle tension.
Measured: Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)
Secondary outcomes (17)
Change from baseline research arm test (ARAT) after intervention
ARAT measures 4 upper extremity functions, including grasp, grip, pinch, and gross motor. It includes 19 items using 4-point scale (0-1-2-3). Total score is 57.A higher score indicates that the patient has higher upper extremity function.
Measured: Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)
Change from baseline Barthel Index(BI) after intervention
Barthel Index with total possible scores ranging from 0 to 20 is utilized to estimate patients' basic functions in daily life. It has 10 items. Higher scores indicate higher independence in daily life.
Measured: Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)
Change from baseline Patient Health Questionnaire (PHQ-9) after intervention
PHQ-9 is used to evaluate patients' depressive symptoms. PHQ-9 includes 9 items, using 4-point scale (0-1-2-3) to estimate the appearance frequency of each depressive symptom. Total possible scores range from 0 to 27, and a higher score indicates a higher appearance frequency of melancholic symptoms.
Measured: Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)
Change from baseline fMRI activation after intervention
3T Siemens whole body nuclear magnetic resonance imaging system (Trio, Siemens, Erlangen, Germany) with 32-channel phase-array head coil is utilized to collect image information.
Patients put left and right hands in left and right pneumatic 10-finger stimulators (Mag Design and Engineering, USA), respectively. This instrument does not have any invasive risk.
Measured: Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)
Change from baseline Diffusion Spectrum Imaging after intervention
3T Siemens whole body nuclear magnetic resonance imaging system (Trio, Siemens, Erlangen, Germany) with 32-channel phase-array head coil is utilized to collect image information.
Patients are asked to lie down and keep relax on the scanning table for 20 minutes. This instrument does not have any invasive risk.
Patients' corticospinal tract structural integrity will be analyzed after imaging preprocessing.
Measured: Assessed at the baseline section (within 7 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 7 days after the latest intervention section).
Change from baseline research arm test (ARAT) at 3 months after intervention
ARAT measures 4 upper extremity functions, including grasp, grip, pinch, and gross motor. It includes 19 items using 4-point scale (0-1-2-3). Total score is 57.A higher score indicates that the patient has higher upper extremity function.
Measured: Assessed at 3 months after intervention
Change from baseline research arm test (ARAT) at 6 months after intervention
ARAT measures 4 upper extremity functions, including grasp, grip, pinch, and gross motor. It includes 19 items using 4-point scale (0-1-2-3). Total score is 57.A higher score indicates that the patient has higher upper extremity function.
Measured: Assessed at 6 months after intervention
Change from baseline Barthel Index(BI) at 3 months after intervention
Barthel Index with total possible scores ranging from 0 to 20 is utilized to estimate patients' basic functions in daily life. It has 10 items. Higher scores indicate higher independence in daily life.
Measured: Assessed at 3 months after intervention
Change from baseline Patient Health Questionnaire (PHQ-9) at 3 months after intervention
PHQ-9 is used to evaluate patients' depressive symptoms. PHQ-9 includes 9 items, using 4-point scale (0-1-2-3) to estimate the appearance frequency of each depressive symptom. Total possible scores range from 0 to 27, and a higher score indicates a higher appearance frequency of melancholic symptoms.
Measured: Assessed at 3 months after intervention
Change from baseline Barthel Index(BI) at 6 months after intervention
Barthel Index with total possible scores ranging from 0 to 20 is utilized to estimate patients' basic functions in daily life. It has 10 items. Higher scores indicate higher independence in daily life.
Measured: Assessed at 6 months after intervention
Change from baseline Patient Health Questionnaire (PHQ-9) at 6 months after intervention
PHQ-9 is used to evaluate patients' depressive symptoms. PHQ-9 includes 9 items, using 4-point scale (0-1-2-3) to estimate the appearance frequency of each depressive symptom. Total possible scores range from 0 to 27, and a higher score indicates a higher appearance frequency of melancholic symptoms.
Measured: Assessed at 6 months after intervention
Change from baseline Fugl Meyer Assessment(FMA)upper extremities subscale at 3 months after intervention
FMA-UE estimates the movement of proximal upper extremity (including shoulder joint, elbow joint and forearm), wrist joint and hand.
Each movement is estimated by 3 scaled rules (0-1-2): score 0 indicates that the patient has no movement at all; score 1 indicates that the patient can perform partial movements; score 2 indicates that the patient can normally perform all movements.
The total score in the differential scale is 66, and a higher score indicates that the patient has better movement ability.
Measured: Assessed at 3 months after intervention
Change from baseline Active joint activity at 3 months after intervention
A protractor is used to estimate 4 active joint activities of patients,including wrist extension, carpometacarpal extension, metacarpophalangeal extension, and shoulder flexion.
Measured: Assessed at 3 months after intervention
Change from baseline Muscle tone at 3 months after intervention
Motor assessment scale (MAS) is used to estimate muscle tension in patients, and the estimated muscles include the flexors and extensors of elbow, wrist and metacarpophalangeal joints.
MAS is totally divided into 6 scales (0, 1, 1+, 2, 3, 4), and a higher score indicates that the patient has higher muscle tension.
Measured: Assessed at 3 months after intervention
Change from baseline Fugl Meyer Assessment(FMA)upper extremities subscale at 6 months after intervention
FMA-UE estimates the movement of proximal upper extremity (including shoulder joint, elbow joint and forearm), wrist joint and hand.
Each movement is estimated by 3 scaled rules (0-1-2): score 0 indicates that the patient has no movement at all; score 1 indicates that the patient can perform partial movements; score 2 indicates that the patient can normally perform all movements.
The total score in the differential scale is 66, and a higher score indicates that the patient has better movement ability.
Measured: Assessed at 6 months after intervention
Change from baseline Active joint activity at 6 months after intervention
A protractor is used to estimate 4 active joint activities of patients,including wrist extension, carpometacarpal extension, metacarpophalangeal extension, and shoulder flexion.
Measured: Assessed at 6 months after intervention
Change from baseline Muscle tone at 6 months after intervention
Motor assessment scale (MAS) is used to estimate muscle tension in patients, and the estimated muscles include the flexors and extensors of elbow, wrist and metacarpophalangeal joints.
MAS is totally divided into 6 scales (0, 1, 1+, 2, 3, 4), and a higher score indicates that the patient has higher muscle tension.
Measured: Assessed at 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Jiann-Shing Jeng, Doctor, Principal investigator, Department of Neurology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847157
- Sponsor's protocol ID
- 201202016RIB
- Status last verified
- Feb 2016
- First submitted
- 22 Apr 2013
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lindenberg R, Renga V, Zhu LL, Nair D, Schlaug G. Bihemispheric brain stimulation facilitates motor recovery in chronic stroke patients. Neurology. 2010 Dec 14;75(24):2176-84. doi: 10.1212/WNL.0b013e318202013a. Epub 2010 Nov 10.
PubMed 21068427Hesse S, Waldner A, Mehrholz J, Tomelleri C, Pohl M, Werner C. Combined transcranial direct current stimulation and robot-assisted arm training in subacute stroke patients: an exploratory, randomized multicenter trial. Neurorehabil Neural Repair. 2011 Nov-Dec;25(9):838-46. doi: 10.1177/1545968311413906. Epub 2011 Aug 8.
PubMed 21825004Stagg CJ, Nitsche MA. Physiological basis of transcranial direct current stimulation. Neuroscientist. 2011 Feb;17(1):37-53. doi: 10.1177/1073858410386614.
PubMed 21343407Stagg CJ, Bachtiar V, O'Shea J, Allman C, Bosnell RA, Kischka U, Matthews PM, Johansen-Berg H. Cortical activation changes underlying stimulation-induced behavioural gains in chronic stroke. Brain. 2012 Jan;135(Pt 1):276-84. doi: 10.1093/brain/awr313. Epub 2011 Dec 6.
PubMed 22155982Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.
PubMed 20633386Weiss T, Sens E, Teschner U, Meissner W, Preul C, Witte OW, Miltner WH. Deafferentation of the affected arm: a method to improve rehabilitation? Stroke. 2011 May;42(5):1363-70. doi: 10.1161/STROKEAHA.110.601138. Epub 2011 Mar 31.
PubMed 21454817Ward NS, Cohen LG. Mechanisms underlying recovery of motor function after stroke. Arch Neurol. 2004 Dec;61(12):1844-8. doi: 10.1001/archneur.61.12.1844.
PubMed 15596603Koh CL, Lin JH, Jeng JS, Huang SL, Hsieh CL. Effects of Transcranial Direct Current Stimulation With Sensory Modulation on Stroke Motor Rehabilitation: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Dec;98(12):2477-2484. doi: 10.1016/j.apmr.2017.05.025. Epub 2017 Jun 24.
PubMed 28652065
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Transcranial Direct Current Stimulation Combined Sensory Modulation Intervention on Upper Extremity Functional Rehabilitation in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT01847157
- Acronym / sponsor ID
- 201202016RIB
- Conditions
- Stroke
- Keywords
- recovery of function, stroke, Upper extremity, Motor, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background and purpose:
About 30% of people with stroke suffered from severe long-term upper extremity （UE） motor impairment. Severe UE impairment, especially dysfunction of hand, can greatly impact stroke patients' daily living independence and quality of life. However, treatment effect of current interventions is still limited. Nick Ward and Leonardo Cohen suggested 5 intervention strategies for stroke motor recovery: （1） reduction of somatosensory input from the intact; （2） increase in somatosensory input from the paretic; （3） anesthesia of a body part proximal to the paretic hand; （4） activity within the affected motor cortex may be up-regulated; （5） activity within the intact motor cortex may be down-regulated. Recent studies have shown each strategy to be effective in stroke patients with mild or moderate UE impairment. However, evidence for people with severe UE impairment after stroke remains unclear. Since research has found a greater effect for combined strategies than a single strategy, this proposal develops a combined intervention with the above 5 strategies, named "transcranial direct current stimulation （tDCS） combined sensory modulation intervention". This intervention is expected to be most effective for people with severe UE impairment after stroke.
In addition, neuroimaging can provide in vivo information about the brain plasticity which underpinning the motor recovery after stroke. However, image indexes that can be used in stroke patients with severe UE impairment remained examined. Therefore, this proposal has 3 aims: （1） to examine the treatment effect of the "tDCS combined sensory modulation intervention" in stroke patients with severe UE impairment; （2） to examine the underline mechanism of the efficacy of "tDCS combined sensory modulation intervention" using neuroimaging technology.
Methods:
This study is a double-blinded randomized controlled trial which will recruit 60 people who have had stroke onset more than 6 months and have severe UE motor impairment. All participants will be randomly assigned into 2 groups. The experimental group will be given the "tDCS combined sensory modulation intervention", combining bilateral tDCS stimulation, anesthesia techniques and repetitive passive motor training. The control group is given sham tDCS, sham anesthesia and repetitive passive motor training. Each group will be evaluated for outcomes at 4 time points （i.e. baseline, post-intervention, 3 months and 6months post-intervention）. The immediate and long-term effect of the interventions will be examined.
Primary outcome indicators include upper extremity impairment measures. Secondary outcome measures include upper extremity function, activities of daily living function, functional Magnetic Resonance Imaging （fMRI）, and corticospinal tract structural integrity using diffusion spectrum imaging （DSI）. Fifteen subjects of each group will be assessed 2 times （i.e., prior to the intervention and after the intervention） for fMRI and DSI scan.
Anticipatory results and contributions:
The results of the studies are expected to present a potentially effective intervention for stroke patients with severe impaired UE motor. Imaging evidence of brain plasticity for this particular intervention is also provided. The results will contribute to our understanding of brain plasticity for UE motor recovery after stroke. Findings from this proposal may help researchers and clinicians choose or develop interventions that are optimal to their clients individually.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS & epidermis anesthesia & repeated passive movement | Experimental | Device: tDCS, Drug: Epidermis anesthesia, Other: Repeated passive movementThe patients in the experiment group will receive multi-strategy combination treatment mode- "combined tDCS and sensory input regulation treatment mode", including bilateral tDCS , epidermis anesthesia in the proximal hand of affected side and in the distal hand of unaffected side , and repeated passive movement training for the hand of affected side. Treatment modes are 3 times a week, 30 minutes each time, lasting for 8 weeks, and totally 24 trainings. The treatment content of each strategy is separately described in the following. |
| Shame tDCS & sham anesthesia & repeated passive movement | Sham comparator | Drug: sham anesthesia, Other: Repeated passive movement, Device: sham tDCSthe control group is "repeated passive movement stimulation", including sham bilateral tDCS, sham epidermis anesthesia in the proximal hand of affected side and in the distal hand of unaffected side, and repeated passive movement training for the hand of affected side. Treatment modes are 3 times a week, 30 minutes each time, lasting for 8 weeks, and totally 24 trainings. The treatment content of each strategy is separately described in the following. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- first ever ischemic or hemorrhagic stroke patients identified by computed tomography (CT) or magnetic resonance imaging (MRI)
- age between 40 and 80 years old
- have a stroke over 6 months
- unilateral hemiplegia
- Fugl-Meyer assessment-upper extremity (FMA-UE) score≦29 when selection
Key exclusion criteria (7 listed)
- Suffer from other orthopedic diseases (such as severe arthritis), nerve damage (such as peripheral nerve damage), or severe pain, which influences upper extremity motor
- have a medical history or family history of epilepsy
- regularly take central nervous system drugs (such as sedatives), or the Class III antiarrhythmic drugs (such as amiodarone)
- have atopic dermatitis or skin disorders of the scalp
- have allergy to anesthetic medicines of the acyl amine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSAlso: Intelect mobile combinationIntelect mobile combination (Intelect, USA) is utilized as a direct current stimulator. The 25 cm2 electrodes on a sponge slice immersed in physiological salt solution are fixed on the left and right positions C3/ C4 of subject head (according to the international 10-20 system of electroencephalogram). During the treatment, 1.5 mA electric current is applied to stimulate the subjects in the experimental group for totally 30 minutes. At the start and the end of stimulation, the electric current will gradually increase from zero, or reduce to zero in 1 minute in order to avoid the possible appearance of slight flash effect of subject eyesight, which is caused by instantly turning on or turning off the electric current. | Device | tDCS & epidermis anesthesia & repeated passive movement |
| Epidermis anesthesiaAlso: Emla 5% cream (Lignocaine 2.5% / Prilocaine 2.5%)15 g of Emla 5% Cream(anesthetic) is applied to the ventral surface of the forearm of unaffected side with a distance of 10 mm from the wrist, and an area of 150 mm long x 50 mm wide. Furthermore, 10 g Emla 5% Cream(anesthetic) is applied to the ventral surface of the upper arm of affected side with a distance of 10 mm from the wrist, and an area of 100 mm long x 50 mm wide. | Drug | tDCS & epidermis anesthesia & repeated passive movement |
| sham anesthesiaAlso: Cetaphil, body cream15 g of 5% body Cream is applied to the ventral surface of the forearm of unaffected side with a distance of 10 mm from the wrist, and an area of 150 mm long x 50 mm wide. 10 g body Cream is applied to the ventral surface of the upper arm of affected side with a distance of 10 mm from the wrist, and an area of 100 mm long x 50 mm wide. | Drug | Shame tDCS & sham anesthesia & repeated passive movement |
| Repeated passive movementRepeated passive wrist extension training: Patients' wrist joint are passively moved by a trained occupational therapist (joint moving angle = 0- 60 degree), frequency 1 Hz, maintain for 20 minutes. Finger passive flexion and extension training: Patients' fingers joint are passively moved by a trained occupational therapist, frequency 1 Hz, maintain for 10 minutes. | Other | Shame tDCS & sham anesthesia & repeated passive movement, tDCS & epidermis anesthesia & repeated passive movement |
| sham tDCSAlso: Intelect mobile combinationThe equipment of sham stimulation in the control group is exactly the same as the equipment in the experiment group. However, the only difference is that 30 seconds after the start of electric current, the experimenter turns off the powder under subject ignorance situation. The stimulation just gives patients weak sense of electric current, in order to blind them for which group they are in. | Device | Shame tDCS & sham anesthesia & repeated passive movement |
Primary outcome
Change from baseline Fugl Meyer Assessment(FMA)upper extremities subscale after intervention
Time frame: Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)
FMA-UE estimates the movement of proximal upper extremity (including shoulder joint, elbow joint and forearm), wrist joint and hand. Each movement is estimated by 3 scaled rules (0-1-2): score 0 indicates that the patient has no movement at all; score 1 indicates that the patient can perform partial movements; score 2 indicates that the patient can normally perform all movements. The total score in the differential scale is 66, and a higher score indicates that the patient has better movement ability.
Change from baseline Active joint activity after intervention
Time frame: Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)
A protractor is used to estimate 4 active joint activities of patients,including wrist extension, carpometacarpal extension, metacarpophalangeal extension, and shoulder flexion.
Change from baseline Muscle tone after intervention
Time frame: Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)
Motor assessment scale (MAS) is used to estimate muscle tension in patients, and the estimated muscles include the flexors and extensors of elbow, wrist and metacarpophalangeal joints. MAS is totally divided into 6 scales (0, 1, 1+, 2, 3, 4), and a higher score indicates that the patient has higher muscle tension.
17 secondary outcomes
Change from baseline research arm test (ARAT) after intervention
Time frame: Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)
Change from baseline Barthel Index(BI) after intervention
Time frame: Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)
Change from baseline Patient Health Questionnaire (PHQ-9) after intervention
Time frame: Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)
Change from baseline fMRI activation after intervention
Time frame: Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)
Change from baseline Diffusion Spectrum Imaging after intervention
Time frame: Assessed at the baseline section (within 7 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 7 days after the latest intervention section).
Change from baseline research arm test (ARAT) at 3 months after intervention
Time frame: Assessed at 3 months after intervention
Change from baseline research arm test (ARAT) at 6 months after intervention
Time frame: Assessed at 6 months after intervention
Change from baseline Barthel Index(BI) at 3 months after intervention
Time frame: Assessed at 3 months after intervention
Change from baseline Patient Health Questionnaire (PHQ-9) at 3 months after intervention
Time frame: Assessed at 3 months after intervention
Change from baseline Barthel Index(BI) at 6 months after intervention
Time frame: Assessed at 6 months after intervention
Change from baseline Patient Health Questionnaire (PHQ-9) at 6 months after intervention
Time frame: Assessed at 6 months after intervention
Change from baseline Fugl Meyer Assessment(FMA)upper extremities subscale at 3 months after intervention
Time frame: Assessed at 3 months after intervention
Change from baseline Active joint activity at 3 months after intervention
Time frame: Assessed at 3 months after intervention
Change from baseline Muscle tone at 3 months after intervention
Time frame: Assessed at 3 months after intervention
Change from baseline Fugl Meyer Assessment(FMA)upper extremities subscale at 6 months after intervention
Time frame: Assessed at 6 months after intervention
Change from baseline Active joint activity at 6 months after intervention
Time frame: Assessed at 6 months after intervention
Change from baseline Muscle tone at 6 months after intervention
Time frame: Assessed at 6 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Background: PubMed 21068427Lindenberg R, Renga V, Zhu LL, Nair D, Schlaug G. Bihemispheric brain stimulation facilitates motor recovery in chronic stroke patients. Neurology. 2010 Dec 14;75(24):2176-84. doi: 10.1212/WNL.0b013e318202013a. Epub 2010 Nov 10.
- Background: PubMed 21825004Hesse S, Waldner A, Mehrholz J, Tomelleri C, Pohl M, Werner C. Combined transcranial direct current stimulation and robot-assisted arm training in subacute stroke patients: an exploratory, randomized multicenter trial. Neurorehabil Neural Repair. 2011 Nov-Dec;25(9):838-46. doi: 10.1177/1545968311413906. Epub 2011 Aug 8.
- Background: PubMed 21343407Stagg CJ, Nitsche MA. Physiological basis of transcranial direct current stimulation. Neuroscientist. 2011 Feb;17(1):37-53. doi: 10.1177/1073858410386614.
- Background: PubMed 22155982Stagg CJ, Bachtiar V, O'Shea J, Allman C, Bosnell RA, Kischka U, Matthews PM, Johansen-Berg H. Cortical activation changes underlying stimulation-induced behavioural gains in chronic stroke. Brain. 2012 Jan;135(Pt 1):276-84. doi: 10.1093/brain/awr313. Epub 2011 Dec 6.
- Background: PubMed 20633386Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.
- Background: PubMed 21454817Weiss T, Sens E, Teschner U, Meissner W, Preul C, Witte OW, Miltner WH. Deafferentation of the affected arm: a method to improve rehabilitation? Stroke. 2011 May;42(5):1363-70. doi: 10.1161/STROKEAHA.110.601138. Epub 2011 Mar 31.
- Background: PubMed 15596603Ward NS, Cohen LG. Mechanisms underlying recovery of motor function after stroke. Arch Neurol. 2004 Dec;61(12):1844-8. doi: 10.1001/archneur.61.12.1844.
- Derived from this study: PubMed 28652065Koh CL, Lin JH, Jeng JS, Huang SL, Hsieh CL. Effects of Transcranial Direct Current Stimulation With Sensory Modulation on Stroke Motor Rehabilitation: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Dec;98(12):2477-2484. doi: 10.1016/j.apmr.2017.05.025. Epub 2017 Jun 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiann-Shing Jeng, Doctor principal investigator
Department of Neurology, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS, Epidermis anesthesia and Repeated passive movement in people with Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Fugl Meyer Assessment(FMA)upper extremities subscale after intervention (time frame: Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01847157, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.