Trial Outcomes & Findings for Effects Of tDCS With Physical Therapy On Rehabilitation In Parkinson's Disease (NCT NCT01877148)
NCT ID: NCT01877148
Last Updated: 2015-05-15
Results Overview
Unified Parkinson´s Disease Rating Scale is the sum of 27 questions, total score ranging from108 (best possible outcome) to 0 (worst possible outcome)", as accurate and appropriate
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
At baseline, after 1 month
Results posted on
2015-05-15
Participant Flow
Participant milestones
| Measure |
Physiotherapy + Anodal tDCS
The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy
|
Physiotherapy + Sham tDCS
The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects Of tDCS With Physical Therapy On Rehabilitation In Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Physiotherapy + Anodal tDCS
n=5 Participants
The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy
|
Physiotherapy + Sham tDCS
n=5 Participants
The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 9.27 • n=5 Participants
|
68.2 years
STANDARD_DEVIATION 11.75 • n=7 Participants
|
63.6 years
STANDARD_DEVIATION 10.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline, after 1 monthUnified Parkinson´s Disease Rating Scale is the sum of 27 questions, total score ranging from108 (best possible outcome) to 0 (worst possible outcome)", as accurate and appropriate
Outcome measures
| Measure |
Physiotherapy + Anodal tDCS
n=5 Participants
The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy
|
Physiotherapy + Sham tDCS
n=5 Participants
The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy
|
|---|---|---|
|
Change From Unified Parkinson´s Disease Rating Scale - UPDRS
Baseline
|
24 units on a scale
Standard Error 12
|
30 units on a scale
Standard Error 23
|
|
Change From Unified Parkinson´s Disease Rating Scale - UPDRS
post 1 month
|
21.2 units on a scale
Standard Error 11.12
|
21.8 units on a scale
Standard Error 14.0
|
SECONDARY outcome
Timeframe: per sesssion: at baseline and after physical therapyOutcome measures
| Measure |
Physiotherapy + Anodal tDCS
n=5 Participants
The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy
|
Physiotherapy + Sham tDCS
n=5 Participants
The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy
|
|---|---|---|
|
Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation
Baseline
|
1.01 milivolt
Standard Error 0.25
|
1 milivolt
Standard Error 0.22
|
|
Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation
post 1 month
|
1.35 milivolt
Standard Error 0.24
|
1.15 milivolt
Standard Error 0.31
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at baseline, after 1 monthParkinson disease quality of life is the sum of 37 questions, total score ranging from 0 (best possible outcome) to 185 (worst possible outcome)", as accurate and appropriate
Outcome measures
| Measure |
Physiotherapy + Anodal tDCS
n=5 Participants
The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy
|
Physiotherapy + Sham tDCS
n=5 Participants
The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy
|
|---|---|---|
|
Change From Parkinson Disease Quality of Life - PDQL
Baseline
|
112.8 units on a scale
Standard Error 44.1
|
117.2 units on a scale
Standard Error 45.6
|
|
Change From Parkinson Disease Quality of Life - PDQL
post 1 month
|
120.2 units on a scale
Standard Error 35.07
|
125.8 units on a scale
Standard Error 37.83
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline, after 1 monthThe Jebsen-Taylor Hand Function Test assesses a broad range of uni-manual hand functions required for activities of daily living. Seven subtests are performed on both non-dominant and dominant hand: 1. Writing a 24-letter, 3rd grade reading difficulty sentence 2... Total score = sum of times for each subtests. Shorted times are indicative of better hand function
Outcome measures
| Measure |
Physiotherapy + Anodal tDCS
n=5 Participants
The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy
|
Physiotherapy + Sham tDCS
n=5 Participants
The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.
Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability
Physiotherapy
|
|---|---|---|
|
Change From Jebsen-Taylor Hand Function Test - Jebsen Test
Baseline
|
106.36 minutes
Standard Error 55.93
|
90.63 minutes
Standard Error 45.53
|
|
Change From Jebsen-Taylor Hand Function Test - Jebsen Test
post 1 month
|
86.62 minutes
Standard Error 48.71
|
81.29 minutes
Standard Error 27.5
|
Adverse Events
Physiotherapy + Anodal tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Physiotherapy + Sham tDCS
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
Kátia Monte-Silva
Universidade Federal de Pernambuco
Phone: + 55 (81) 2126-7579
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place