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| Name | Class |
|---|---|
| The Parkinson Study Group | NETWORK |
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A Multicenter, Randomized, Blinded, Electronic Device in Subjects with Parkison Disease.
This study is a multi-center, prospective, randomized, double-blinded, sham-controlled, within-subject design, 3-treatment, 3-period cross-over study involving 38 subjects with Parkinson's Disease who have the wearing-off phenomenon on oral levodopa therapy. All participants will receive three treatments on different days, each with different stimulation conditions. All subjects will wear the Earstim device on the ear ipsilateral to the side of the body more affected by Parkinson's Disease for 120 minutes during each of the three treatment applications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Stimulation 20 minutes | Active Comparator | Intramuscular stimulation |
|
| Active Stimulation 60 minutes | Active Comparator | Intramuscular stimulation |
|
| Sham Stimulation 20 minutes | Sham Comparator | Muscle-free-zone stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Earstim - Active Stimulation | Device | Intramuscular stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Score) at 20 minutes | The primary efficacy endpoint is the overall change from baseline to 20 minutes after onset of stimulation in MDS-UPDRS motor score (MDS-UPDRS Part III), comparing the sham arm vs the average 20-minute change of the 20-minute and 60-minute auricular stimulation. Each parkinsonian sign or symptom is rated on a 5-point Likert-type scale (ranging from 0 to 4), with higher scores indicating more severe impairment. | Baseline, 20 minutes after the stimulation is initiated |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve | The area under the curve (AUC) of change from prior to stimulation in MDS-UPDRS Part III total motor score over the entire 120 minute post-stimulation follow-up interval, comparing the sham treatment to the 20 and 60 minute treatments with auricular muscle zone stimulation by subject and by treatment group. | 120 minutes after stimulation is initiated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yusuf O Cakmak, MD, PhD | Stoparkinson Healthcare Systems LLC | Study Director |
| Stanley Fahn, MD | H. Houston Merritt Professor of Neurology, Columbia University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| Rocky Mountain Movement Disorder's Center, PC |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Earstim - Sham Stimulation | Device | Sham stimulation |
|
| Maximal improvement in MDS-UPDRS motor score (MDS-UPDRS Part III) from prior to stimulation to any of the follow-up time points up to 120 minutes after onset of stimulation. | Maximal improvement in MDS-UPDRS motor score (MDS-UPDRS Part III) from prior to stimulation to any of the follow-up time points (20 ,40, 60, 90, and 120 minutes after onset of stimulation). Each parkinsonian sign or symptom is rated on a 5-point Likert-type scale (ranging from 0 to 4), with higher scores indicating more severe impairment | 120 minutes after stimulation is initiated. |
| Patient Global Impression of Change (PGIC) scored by the subject prior to stimulation and at the follow-up time points up to 120 minutes after onset of stimulation. | Patient Global Impression of Change (PGIC) scored by the subject prior to stimulation and at the follow-up time points (20,40, 60, 90, and 120 minutes after onset of stimulation). Seven point Likert scale ranging from 1= much worse to 7= much better | 120 minutes after stimulation is initiated. |
| Timed Get Up and Go test prior to stimulation and at the follow-up time points up to 120 minutes after onset of stimulation. | Timed Get Up and Go test prior to stimulation and at the follow-up time points (20 ,40, 60, 90, and 120 minutes after onset of stimulation). | 120 minutes after stimulation is initiated. |
| Clinical Global Impression of Change (CGIC) prior to stimulation and at the follow-up time points up to 120 minutes after onset of stimulation. | Clinical Global Impression of Change (CGIC) prior to stimulation and at the follow-up time points (20 ,40, 60, 90, and 120 minutes after onset of stimulation). Seven point Likert scale ranging from 1= much worse to 7= much better | Baseline, 120 minutes after stimulation is initiated. |
| Kinesia-ONE™ Variable: Finger Tapping Speed Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation. | Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. | 120 minutes after stimulation is initiated. |
| Kinesia-ONE™ Variable: Rest Tremor Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation. | Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. | 120 minutes after stimulation is initiated. |
| Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores comparison between each study arm at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation. | The finger tapping speed scores and resting tremor scores were averaged and provided as one score ranging from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. | 120 minutes after stimulation is initiated. |
| Kinesia-ONE™ Variable: Postural Tremor Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation. | Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. | 120 minutes after stimulation is initiated. |
| Kinesia-ONE™ Variable: Finger Tapping Amplitude Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation. | Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. | 120 minutes after stimulation is initiated. |
| Kinesia-ONE™ Variable: Hand Grasp Speed Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation. | Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. | 120 minutes after stimulation is initiated. |
| Kinesia-ONE™ Variable: Hand Grasp Amplitude Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation. | Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. | 120 minutes after stimulation is initiated. |
| Kinesia-ONE™ Variable: Rapid Alternating Movement Speed Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation. | Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. | 120 minutes after stimulation is initiated. |
| Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation. | Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. | 120 minutes after stimulation is initiated. |
| Kinesia-ONE™ Variable: Dyskinesia Score comparison between the three different treatments at the specified times of just before stimulation and at the follow-up time points up to 120 minutes after onset of stimulation. | Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms. | 120 minutes after stimulation is initiated. |
| Determination by the investigator of dyskinesia severity by MDS-UPDRS Part IV prior to stimulation and at the follow-up time points up to 120 minutes after onset of stimulation. | Determination by the investigator of dyskinesia severity by MDS-UPDRS Part IV prior to stimulation and at the follow-up time points (20 ,40, 60, 90, and 120 minutes after onset of stimulation). dyskinesia severity is rated on a 5-point Likert-type scale (ranging from 0 to 4), with higher scores indicating more severe impairment | 120 minutes after stimulation is initiated |
| Determination by a consensus between subject and investigator of whether the subject is "OFF" or "ON" prior to stimulation and at the follow-up time points up to 120 minutes after onset of stimulation. | Determination by a consensus between subject and investigator of whether the subject is "OFF" or "ON" prior to stimulation and at the follow-up time points (20 ,40, 60, 90, and 120 minutes after onset of stimulation). | 120 minutes after stimulation is initiated. |
| Change in mood as measured by the Depressed Mood Score from baseline to 120 minutes after onset of stimulation. | Change in mood as measured by the Depressed Mood Score in Part I of MDS-UPDRS from pre-stimulation to 120 minutes after onset of stimulation. | 120 minutes after stimulation is initiated. |
| Change in mood as measured by the Anxiety Mood Score from baseline to 120 minutes after onset of stimulation. | Change in mood as measured by the Anxiety Mood Score in Part I of MDS-UPDRS from pre-stimulation to 120 minutes after onset of stimulation. | 120 minutes after stimulation is initiated. |
| Change in subjects' sense of well-being as measured by an exploratory ordinal scale prior to stimulation and at the follow-up time points up to 120 minutes after onset of stimulation. | Change in subjects' sense of well-being as measured by an exploratory ordinal scale prior to stimulation and at the follow-up time points (20 ,40, 60, 90, and 120 minutes after onset of stimulation). Scores ranged from +3 to -3 (+3 represents more comfortable - much greater peace of mind; and -3 represents more uncomfortable and have a much greater worse peace of mind | 120 minutes after stimulation is initiated. |
| Englewood |
| Colorado |
| 80113 |
| United States |
| Parkinson Disease and Movement Disorder Center of Boca Raton | Boca Raton | Florida | 33486 | United States |
| University of Florida | Gainesville | Florida | 32608 | United States |
| Rush University | Chicago | Illinois | 60612 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| University of Kansas | Kansas City | Kansas | 66160 | United States |
| Booth Gardner Parkinson's Care Center | Kirkland | Washington | 98034 | United States |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |