Trial Outcomes & Findings for Transcranial Magnetic Stimulation to Improve Speech in Aphasia (NCT NCT00608582)
NCT ID: NCT00608582
Last Updated: 2017-01-31
Results Overview
Pictures named correctly on Boston Naming Test (BNT), First 20 Pictures
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
63 participants
Primary outcome timeframe
Baseline and 2 months after the last rTMS treatment session
Results posted on
2017-01-31
Participant Flow
July 2002-March 2013. Recruited in hospital setting and outreach with affiliated and local clinics VA Boston Healthcare System, Boston, MA; Hospital of the University of Pennsylvania, Philadelphia, PA
Assessed for eligibility by telephone screen, or in-office visit. Assessment included review of medical history. Total Excluded (n = 38) Not meeting inclusion criteria (n = 31) Declined to participate (n = 2) Other reasons (n = 5)
Participant milestones
| Measure |
Real rTMS
These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.
|
Sham rTMS
These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil.
There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment.
The patients then receive a series of 10 Real rTMS treatments.
Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
|
Overall Study
COMPLETED
|
10
|
7
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Real rTMS
These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.
|
Sham rTMS
These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil.
There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment.
The patients then receive a series of 10 Real rTMS treatments.
Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
No Best Response in Phase 1 located
|
1
|
1
|
|
Overall Study
Illicit Drug Use
|
1
|
0
|
|
Overall Study
Early stage Design Change
|
0
|
3
|
Baseline Characteristics
Transcranial Magnetic Stimulation to Improve Speech in Aphasia
Baseline characteristics by cohort
| Measure |
Real rTMS
n=14 Participants
These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.
|
Sham rTMS
n=11 Participants
These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil.
The patients then receive a series of 10 Real rTMS treatments. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 11 • n=7 Participants
|
59.28 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Gender
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Gender
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Months Poststroke Onset
|
66 months
STANDARD_DEVIATION 40 • n=5 Participants
|
51 months
STANDARD_DEVIATION 37 • n=7 Participants
|
59 months
STANDARD_DEVIATION 39 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2 months after the last rTMS treatment sessionPopulation: Chronic Stroke Patients with Aphasia who receive either a Real rTMS series or a Sham rTMS series
Pictures named correctly on Boston Naming Test (BNT), First 20 Pictures
Outcome measures
| Measure |
Real rTMS
n=10 Participants
These patients receive a series of 10 Real Transcranial Magnetic Stimulation, Repetitive (rTMS) , treatments, only. There is pre-testing and post-testing at 2 months after the last Real rTMS treatment.
Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.
|
Sham rTMS
n=7 Participants
Patients receive a series of 10 Sham Transcranial Magnetic Stimulation, Repetitive (rTMS) treatments, followed by a series of 10 Real rTMS treatments. Sham rTMS are identical to the Real rTMS treatments only no magnetic pulse is released. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
|
|---|---|---|
|
Picture Naming
Baseline
|
10.3 number of pictures
Standard Deviation 6.11
|
12.57 number of pictures
Standard Deviation 5.88
|
|
Picture Naming
2 Mo. Post rTMS
|
12.1 number of pictures
Standard Deviation 5.55
|
11.14 number of pictures
Standard Deviation 3.24
|
PRIMARY outcome
Timeframe: Baseline and 2 months after the last rTMS treatment sessionPopulation: Chronic Stroke Patients with Aphasia who received either Real rTMS or Sham rTMS
Longest Number of Words per Phrase Length, for elicited propositional speech for BDAE Cookie Theft Picture Description
Outcome measures
| Measure |
Real rTMS
n=10 Participants
These patients receive a series of 10 Real Transcranial Magnetic Stimulation, Repetitive (rTMS) , treatments, only. There is pre-testing and post-testing at 2 months after the last Real rTMS treatment.
Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.
|
Sham rTMS
n=7 Participants
Patients receive a series of 10 Sham Transcranial Magnetic Stimulation, Repetitive (rTMS) treatments, followed by a series of 10 Real rTMS treatments. Sham rTMS are identical to the Real rTMS treatments only no magnetic pulse is released. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
|
|---|---|---|
|
Phrase Length
2 Mo. Post rTMS
|
5.7 number of words per phrase length
Standard Deviation 3.02
|
5.0 number of words per phrase length
Standard Deviation 3.0
|
|
Phrase Length
Baseline
|
5.2 number of words per phrase length
Standard Deviation 3.05
|
5.285 number of words per phrase length
Standard Deviation 3.35
|
Adverse Events
Real rTMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham rTMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Margaret Naeser, PhD
VA Boston Healthcare System and Boston University School of Medicine
Phone: 857-364-4030
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place