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difficult to recruit participants
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This study will evaluate the effects of transcranial direct current stimulation (tDCS) in combination with locomotor training in patients with Parkinson's disease (PD) and freezing of gait (FOG).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS+ LT | Experimental | Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Device | Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Walking Speed | walking speed will be measured using sensors during a 90 second walk | baseline, 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Motor Scores as Measured by Unified Parkinson's Disease Rating Scale (UPDRS) | UPDRS motor score range from 0-56 with higher scores indicating greater impairment. | baseline, 3 weeks |
| Change in Stride Length |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corneliu Luca, MD, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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One participant was removed from the study and re-enrolled. However, this participant did not complete the study intervention on their first or second enrollment. Therefore their data has not been included in any of the outcome measures.
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| ID | Title | Description |
|---|---|---|
| FG000 | tDCS+ LT | Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks. Transcranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor. locomotor training: An individualized dual-task walking program for approximately 30 minutes. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | tDCS+ LT | Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks. Transcranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor. locomotor training: An individualized dual-task walking program for approximately 30 minutes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Walking Speed | walking speed will be measured using sensors during a 90 second walk | Unable to retrieve collected data on the other 5 participants who completed the study due to a malfunction in the sensors. | Posted | Mean | Standard Deviation | m/s | baseline, 3 weeks |
|
3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | tDCS+ LT | Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks. Transcranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor. locomotor training: An individualized dual-task walking program for approximately 30 minutes. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizziness | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fall at home | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Data was not collected on 4 of the outcome measures due to lack of funding which contributed to the difficulty in performing the tests required per protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corneliu Luca, MD | University of Miami | 305-243-6732 | cluca@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 2, 2016 | May 26, 2020 | Prot_SAP_000.pdf |
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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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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
| locomotor training | Other | An individualized dual-task walking program for approximately 30 minutes. |
|
Stride length is measured with mobile sensors attached to participant's extremities during the 90 second walk.
| baseline, 3 weeks |
| Change in Postural Sway | Postural sway is measured with mobile sensors attached to participant's extremities during the 30 seconds of quiet standing. | baseline, 3 weeks |
| Change in Timed Up-and-Go (TUG) Time | Participants are timed while standing up from a chair, walking around a cone, and returning to their chair. | baseline, 3 weeks |
| Change in Motor Threshold | Transcranial magnetic stimulation is used to measure motor threshold of the primary motor area. The motor threshold was defined as the minimum intensity needed to evoke 5 out 10 motor evoked potentials in the first dorsal interosseous muscle in the hand. | baseline, 3 weeks |
| Change in Glutamate/Gamma Aminobutyric Acid(GABA) Ratio | Glutamate/GABA ratio will be measured with magnetic Resonance Spectroscopy (MRS). | baseline, 3 weeks |
| Change in Backward Digit Span | Digit span is measured by total number of correct digits recited. | baseline, 3 weeks |
| Change in the Trail Making Test Time | Trail making test is measured as the number of seconds required to complete the task, with higher scores indicating greater impairment. | baseline, 3 weeks |
| Change in the Montreal Cognitive Assessment (MOCA) | The MOCA has a total score ranging from 0-30 with a higher score indicating better performance. | baseline, 3 weeks |
| Change in the Auditory Consonant Trigrams Test (ACT) | The ACT has a score from 0-60 with higher score indicating better performance. | baseline, 3 weeks |
| Change in the Freezing of Gait Questionnaire (FOG-Q) | The FOG-Q has a total score ranging from 0-24 with higher scores indicating more incidents of freezing. | baseline, 3 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Change in Motor Scores as Measured by Unified Parkinson's Disease Rating Scale (UPDRS) | UPDRS motor score range from 0-56 with higher scores indicating greater impairment. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 weeks |
|
|
|
| Secondary | Change in Stride Length | Stride length is measured with mobile sensors attached to participant's extremities during the 90 second walk. | Unable to retrieve collected data on the other 5 participants who completed the study due to a malfunction in the sensors. | Posted | Mean | Standard Deviation | m | baseline, 3 weeks |
|
|
|
| Secondary | Change in Postural Sway | Postural sway is measured with mobile sensors attached to participant's extremities during the 30 seconds of quiet standing. | Posted | Mean | Standard Deviation | m^2/s^5 | baseline, 3 weeks |
|
|
|
| Secondary | Change in Timed Up-and-Go (TUG) Time | Participants are timed while standing up from a chair, walking around a cone, and returning to their chair. | Posted | Mean | Standard Deviation | seconds | baseline, 3 weeks |
|
|
|
| Secondary | Change in Motor Threshold | Transcranial magnetic stimulation is used to measure motor threshold of the primary motor area. The motor threshold was defined as the minimum intensity needed to evoke 5 out 10 motor evoked potentials in the first dorsal interosseous muscle in the hand. | 3-week data not collected for 5 participants who completed the study. | Posted | Mean | Standard Deviation | percentage of TMS output | baseline, 3 weeks |
|
|
|
| Secondary | Change in Glutamate/Gamma Aminobutyric Acid(GABA) Ratio | Glutamate/GABA ratio will be measured with magnetic Resonance Spectroscopy (MRS). | No data was collected for this outcome measure. | Posted | baseline, 3 weeks |
|
|
| Secondary | Change in Backward Digit Span | Digit span is measured by total number of correct digits recited. | No data was collected for this outcome measure. | Posted | baseline, 3 weeks |
|
|
| Secondary | Change in the Trail Making Test Time | Trail making test is measured as the number of seconds required to complete the task, with higher scores indicating greater impairment. | No data was collected for this outcome measure. | Posted | baseline, 3 weeks |
|
|
| Secondary | Change in the Montreal Cognitive Assessment (MOCA) | The MOCA has a total score ranging from 0-30 with a higher score indicating better performance. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 weeks |
|
|
|
| Secondary | Change in the Auditory Consonant Trigrams Test (ACT) | The ACT has a score from 0-60 with higher score indicating better performance. | No data was collected for this outcome measure. | Posted | baseline, 3 weeks |
|
|
| Secondary | Change in the Freezing of Gait Questionnaire (FOG-Q) | The FOG-Q has a total score ranging from 0-24 with higher scores indicating more incidents of freezing. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 weeks |
|
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| 0 |
| 9 |
| 1 |
| 9 |
| 1 |
| 9 |
| fatigue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |