Trial Outcomes & Findings for Effect of Repetitive Transcranial Magnetic Stimulation on Language in Alzheimer's Disease (NCT NCT00814697)
NCT ID: NCT00814697
Last Updated: 2014-01-28
Results Overview
Cognitive assessment tasks - Boston Diagnostic Aphasia Examination (BDAE), CFL Category naming (CFL), Mini-Mental State Examination (MMSE) - were administered and scored according to standard procedures before, during and 4 weeks after rTMS. Higher scores are associated with better cognition; No absolute cut-offs were used here as the outcomes were not categorically assessed. Total possible score ranges by test, lowest to highest: BDAE - 0 to 15 CFL - 0 to 62 MMSE - 0 to 30 Full range data and means presented below represents range of scores at 4-weeks post-rTMS treatments.
COMPLETED
PHASE2
12 participants
6 weeks
2014-01-28
Participant Flow
All patients were recruited from a tertiary memory disorders practice. Patients were diagnosed as having probable or possible Alzheimer's Disease (AD), using the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
Exclusion criteria included newly diagnosed AD, pacemaker placement, a history of implanted metal object, seizures or epilepsy, a recent history of migraines, uncontrolled depression and those on medications lowering the seizure threshold.
Participant milestones
| Measure |
rTMS
rTMS treatment in Alzheimer's disease
Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Repetitive Transcranial Magnetic Stimulation on Language in Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
rTMS
n=12 Participants
rTMS treatment in Alzheimer's disease
Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
73.1 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksCognitive assessment tasks - Boston Diagnostic Aphasia Examination (BDAE), CFL Category naming (CFL), Mini-Mental State Examination (MMSE) - were administered and scored according to standard procedures before, during and 4 weeks after rTMS. Higher scores are associated with better cognition; No absolute cut-offs were used here as the outcomes were not categorically assessed. Total possible score ranges by test, lowest to highest: BDAE - 0 to 15 CFL - 0 to 62 MMSE - 0 to 30 Full range data and means presented below represents range of scores at 4-weeks post-rTMS treatments.
Outcome measures
| Measure |
Cognitive Assessment
n=12 Participants
rTMS treatment in Alzheimer's disease
Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients
|
|---|---|
|
Cognitive Assessment Task Scores Before, During and After rTMS.
Mini-Mental State Examination (MMSE)
|
26.9 units on a scale
Full Range 3.80 • Interval 19.0 to 30.0
|
|
Cognitive Assessment Task Scores Before, During and After rTMS.
Boston Diagnostic Aphasia Examination (BDAE)
|
13.3 units on a scale
Full Range 2.12 • Interval 9.0 to 15.0
|
|
Cognitive Assessment Task Scores Before, During and After rTMS.
CFL Category Fluency
|
17.0 units on a scale
Full Range 7.03 • Interval 8.0 to 32.0
|
Adverse Events
rTMS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Gayatri Devi
The NY Memory and Healthy Aging Services
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place