Transcranial Direct Current Stimulation, Improve Functional Motor Recovery, Affected Arm

• Sponsor: University of Oklahoma (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01201629
• Collaborator: VA Office of Research and Development (U.S. Fed)
• Enrollment: 16
• Location: 1
• Arms: 2
• Actual Duration (Months): 62.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Overall goal of this study is to determine if transcranial direct current stimulation (tDCS) plus conventional occupational therapy improves functional motor recovery in the affected arm-hand in patients after an acute ischemic stroke compared to sham tDCS plus conventional occupational therapy, and to obtain information to plan a large randomized controlled trial.

Condition or Disease	Intervention/Treatment	Phase
Brain Infarction; Brain Ischemia	Device: t DC stimulation; Device: tDCStimulation	N/A

Detailed Description

Study design:

Patients Successive admissions to the stroke service of the Veterans Affairs Medical Center with ischemic strokes will participate in this study.

Eligibility criteria:

Inclusion criteria:

1. Unilateral, 1st acute stroke event within 4 weeks of admission to an in-patient rehabilitation facility

2. Ischemic stroke documented clinically and by neuroimaging.

3. Severe upper limb weakness (MRC grade of 2 or less at the shoulder joint)

4. Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.

5. Depressed patients will be included in the study (psychiatrist referral will be made if deemed necessary).

6. Aphasic alert patients will be included in the study provided they were able to follow simple directions by verbal or gestural cues and provided with a written informed consent.

7. Informed consent, from cognitively intact patients (admission Mini Mental Scale Examination [MMSE] greater than or equal to 21). When it is not possible for the patient to provide informed consent or patient is cognitively impaired with MMSE ≤ 20, proxy consent will be obtained from the next of kin (legal authorized representative) according to institutional IRB standards. Informed consent will be obtained by the admitting physicians.

Exclusion criteria:

1. Hemorrhagic strokes

2. Patient's with an episode post-stroke seizure or history of epilepsy.

3. Patients medically unstable, demented, or terminally ill (e.g., patients with stroke as a complication of a terminal cancer).

4. On medications such as botox for spasticity or other medications known to enhance motor recovery such as d-amphetamine,

5. Stroke patients with implanted pacemakers and defibrillators.

6. Refusal to provide informed consent

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Does Transcranial Direct Current Stimulation Improve Functional Motor Recovery in the Affected Arm-Hand in Patients After an Acute Ischemic Stroke: A Randomized Control Trial
• Actual Study Start Date: Sep 16, 2010
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: t DC stimulation Sham transcranial direct current stimulation tDCS induces slight short-lasting tingling with onset of the stimulation. These sensations usually fade away in seconds. Sham interventions are essential to blind the subject and the assessor in order to obtain unbiased assessment of intervention effects	Device: t DC stimulation; tDCS is a non-invasive, non-painful technique that modulates cortical excitability. tDCS can induce intracerebral current flow that is sufficiently large to achieve changes in cortical excitability. Thus, tDCS can be applied to humans non-invasively and painlessly to induce focal, lasting but reversible shifts of cortical excitability.; Other Names: Sham transcranial DC brain stimulator ; Device: tDCStimulation; 1 mA of tDCS will be delivered through surface electrodes (25-35 cm2) to the unaffected motor cortex for 30 min prior to a patient's scheduled OT. In the sham group patient will receive stimulation for 30 seconds only.; Other Names: Experimental tDC stimulator
Experimental: tDC stimulation Actual DC stimulation	Device: t DC stimulation; tDCS is a non-invasive, non-painful technique that modulates cortical excitability. tDCS can induce intracerebral current flow that is sufficiently large to achieve changes in cortical excitability. Thus, tDCS can be applied to humans non-invasively and painlessly to induce focal, lasting but reversible shifts of cortical excitability.; Other Names: Sham transcranial DC brain stimulator ; Device: tDCStimulation; 1 mA of tDCS will be delivered through surface electrodes (25-35 cm2) to the unaffected motor cortex for 30 min prior to a patient's scheduled OT. In the sham group patient will receive stimulation for 30 seconds only.; Other Names: Experimental tDC stimulator

Outcome Measures

Primary Outcome Measures

1. Total Functional Independence Measure (TFIM) Change Scores [from baseline to 4-weeks of therapy]

   The Functional Independence Measure (FIM™) will measure the degree of disability. The FIM scale is a reliable and valid functional assessment measure widely used in rehabilitation settings. The FIM has 18 items and each item is scored on an ordinal scale ranging from 1 to 7. A FIM™ item score of seven is categorized as "complete independence," while a score of one is "total assist" (patient performs less than 25% of task). The total FIM score (TFIM) quantifies level of independence and ranges from 18 (lowest) to 126 (highest) level of independence.

Secondary Outcome Measures

1. Action Research Arm Test (ARAT) Change Scores [baseline to after 4-weeks of therapy]

   The Action Research Arm Test (ARAT) is a standardized ordinal scale that measures upper extremity (arm and hand) function. This test assesses the ability to lift various sized objects to a height of 14.75 inches, move cylindrical shaped objects a distance of 14.75 inches, use pinch grasp to lift varying sized objects (such as a ball bearing, and a marble) between the thumb and the 3rd finger, and perform 3 gross upper extremity movements. Each upper extremity is evaluated individually. Score 0=no arm-hand movement and 57=normal

2. Discharge Disposition [after 4 weeks of intervention]

   Patient discharged home or to sub-acute facility

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Unilateral, 1st acute stroke event within 4 weeks of admission to an in-patient rehabilitation facility

2. Ischemic stroke documented clinically and by neuroimaging.

3. Severe upper limb weakness (MRC grade of 2 or less at the shoulder joint)

4. Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.

5. Depressed patients will be included in the study (psychiatrist referral will be made if deemed necessary).

6. Aphasic alert patients will be included in the study provided they were able to follow simple directions by verbal or gestural cues and provided with a written informed consent.

7. Informed consent, from cognitively intact patients (admission Mini Mental Scale Examination [MMSE] greater than or equal to 21). When it is not possible for the patient to provide informed consent or patient is cognitively impaired with MMSE ≤ 20, proxy consent will be obtained from the next of kin (legal authorized representative) according to institutional IRB standards. Informed consent will be obtained by the admitting physicians.

Exclusion Criteria:

1. Hemorrhagic strokes

2. Patient's with an episode post-stroke seizure or history of epilepsy.

3. Patients medically unstable, demented, or terminally ill (e.g., patients with stroke as a complication of a terminal cancer).

4. On medications such as botox for spasticity or other medications known to enhance motor recovery such as d-amphetamine,

5. Stroke patients with implanted pacemakers and defibrillators.

6. Refusal to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oklahoma City VA Medical Center	Oklahoma City	Oklahoma	United States	73104

Sponsors and Collaborators

• University of Oklahoma
• VA Office of Research and Development

Investigators

• Principal Investigator: Meheroz H Rabadi, MD, MRCPI, Oklahoma University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Oklahoma
• ClinicalTrials.gov Identifier: NCT01201629
• Other Study ID Numbers: 1620
• First Posted: Sep 14, 2010
• Last Update Posted: May 10, 2017
• Last Verified: Mar 1, 2017

• Keywords provided by University of Oklahoma: Ischemic Strokes; t DC stimulation; Functional recovery
• Additional relevant MeSH terms: Brain Ischemia; Brain Infarction; Infarction; Ischemia

Study Results

Participant Flow

Recruitment Details	From 2010 to 12/2015 at the OKC VA Med Center as in-patient
Pre-assignment Detail	No significant events or enrolled participants were excluded.

Arm/Group Title	Experimental (tDCs)	Sham
Arm/Group Description	t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation	8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
Period Title: Overall Study
STARTED	8	8
COMPLETED	8	8
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Experimental (tDCs)	Sham	Total
Arm/Group Description	t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation	8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.	Total of all reporting groups
Overall Participants	8	8	16
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	62 (11)	63 (6)	62 (9)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	8 100%	8 100%	16 100%
Race/Ethnicity, Customized (Count of Participants)
Black	1 12.5%	3 37.5%	4 25%
White	7 87.5%	5 62.5%	12 75%
Region of Enrollment (participants) [Number]
United States	8 100%	8 100%	16 100%
Action Research Arm Test (ARAT) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4 (10.9)	1.9 (4.2)	2.9 (8.1)
Functional Independence Measures (TFIM) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	61 (17)	59 (12)	60 (14)

Outcome Measures

1. Primary Outcome

Title	Total Functional Independence Measure (TFIM) Change Scores
Description	The Functional Independence Measure (FIM™) will measure the degree of disability. The FIM scale is a reliable and valid functional assessment measure widely used in rehabilitation settings. The FIM has 18 items and each item is scored on an ordinal scale ranging from 1 to 7. A FIM™ item score of seven is categorized as "complete independence," while a score of one is "total assist" (patient performs less than 25% of task). The total FIM score (TFIM) quantifies level of independence and ranges from 18 (lowest) to 126 (highest) level of independence.
Time Frame	from baseline to 4-weeks of therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental (tDCs)	Sham
Arm/Group Description	t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation	8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
Measure Participants	8	8
Mean (Standard Deviation) [units on a scale]	22.4 (15.7)	25.3 (9.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental (tDCs), Sham
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.05
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Action Research Arm Test (ARAT) Change Scores
Description	The Action Research Arm Test (ARAT) is a standardized ordinal scale that measures upper extremity (arm and hand) function. This test assesses the ability to lift various sized objects to a height of 14.75 inches, move cylindrical shaped objects a distance of 14.75 inches, use pinch grasp to lift varying sized objects (such as a ball bearing, and a marble) between the thumb and the 3rd finger, and perform 3 gross upper extremity movements. Each upper extremity is evaluated individually. Score 0=no arm-hand movement and 57=normal
Time Frame	baseline to after 4-weeks of therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental (tDCs)	Sham
Arm/Group Description	t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation	8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
Measure Participants	8	8
Mean (Standard Deviation) [units on a scale]	10.1 (13.5)	1.7 (4.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental (tDCs), Sham
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Discharge Disposition
Description	Patient discharged home or to sub-acute facility
Time Frame	after 4 weeks of intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental (tDCs)	Sham
Arm/Group Description	t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation	8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
Measure Participants	8	8
Home	4 50%	3 37.5%
Subacute Facility	4 50%	5 62.5%

Adverse Events

Time Frame	3-months
Arm/Group Title	Experimental (tDCs)		Sham
Arm/Group Description	t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation		8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
All Cause Mortality
	Experimental (tDCs)		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)
Serious Adverse Events
	Experimental (tDCs)		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Experimental (tDCs)		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.