Effects Of tDCS With Physical Therapy On Rehabilitation In Parkinson's Disease

• Sponsor: Universidade Federal de Pernambuco (Other)
• Overall Status: Completed
• CT.gov ID: NCT01877148
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The present study aims to investigate the effect of transcranial direct current stimulation (tDCS) associated with physiotherapy in parkinson´s rehabilitation. Previous studies showed that tDCS could reduce the bradykinesia, one of the symptom of Parkinson disease. In this way, this study will combine tDCS with physiotherapy in order to enhance the motor rehabilitation and the quality of life.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Device: tDCS; Behavioral: Physiotherapy	Phase 2

Detailed Description

12 patients were participated of this study.After screening to check the eligibility criteria and giving informed consent, they were randomized in two groups. All patients were submitted to a 10 therapeutic sessions that occurred 3 times per week.

Before, immediately after and 1 month after the last session patients were submitted to an evaluation with the follow tests: Unified Parkinson´s Disease Rating Scale(UPDRS), Jebsen Taylor Test (JTT) and Parkinson's Disease Quality of Life (PDQL). Furthermore, before and after each session the patients were submitted to transcranial magnetic stimulation (TMS) to evaluate cortical excitability through motor threshold and motor evoked potential.

In experimental sessions, the subjects always received physiotherapy with conventional techniques, the protocol followed the clinical practice guideline for physical therapy in Parkinson disease with the Royal Dutch Society Therapy. During tDCS protocol the patients seated in a comfortable chair with head and arm rests. Continuous current was applied using a pair of saline-soaked surface sponge electrodes (surface 35 cm2), the anode electrode was placed over the primary motor cortex and cathode above contralateral orbit. tDCS was applied of twice stimulation of 13 minutes with 20 minutes of interval between them and a current strength of 1mA. Sham tDCS was applied by current flow of 30s.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of Transcranial Direct Current Stimulation Associated With Physical Therapy on Motor Rehabilitation in Parkinson´s Disease Patients
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: tDCS; 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.; Other Names: non invasive brain stimulation ; Behavioral: Physiotherapy; Physiotherapy protocol followed the guidelines outlined in clinical practice guideline for physical therapy in Parkinson disease of the Royal Dutch society for physical therapy (Keus, 2007). This guideline proposes some objectives for motor rehabilitation in patients with PD, such as: flexibility, strength, coordination, balance, posture and gait. The difficulty of exercises ranged according with Hoehn and Yahr (HY) staging scale. In this way, each stage of HY had a specific physical therapy protocol following the guideline.
Sham Comparator: 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.	Device: tDCS; 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.; Other Names: non invasive brain stimulation ; Behavioral: Physiotherapy; Physiotherapy protocol followed the guidelines outlined in clinical practice guideline for physical therapy in Parkinson disease of the Royal Dutch society for physical therapy (Keus, 2007). This guideline proposes some objectives for motor rehabilitation in patients with PD, such as: flexibility, strength, coordination, balance, posture and gait. The difficulty of exercises ranged according with Hoehn and Yahr (HY) staging scale. In this way, each stage of HY had a specific physical therapy protocol following the guideline.

Outcome Measures

Primary Outcome Measures

1. Change From Unified Parkinson´s Disease Rating Scale - UPDRS [At baseline, after 1 month]

   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

Secondary Outcome Measures

1. Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation [per sesssion: at baseline and after physical therapy]

Other Outcome Measures

1. Change From Parkinson Disease Quality of Life - PDQL [at baseline, after 1 month]

   Parkinson 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

2. Change From Jebsen-Taylor Hand Function Test - Jebsen Test [At baseline, after 1 month]

   The 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Parkinson disease comproved by a neurologist Regular treatment with dopamine or other drugs against parkinson -

Exclusion Criteria:

pregnant history of convulsion metal implant in the region of skull or face change in medication during the study realize other physical therapy in the same time of the study previous surgery for parkinson disease

-

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Applied Neuroscience Laboratory	Recife	Pernambuco	Brazil	50740-560

Sponsors and Collaborators

• Universidade Federal de Pernambuco

Investigators

• Study Director: Kátia K Monte-Silva, PhD, Universidade Federal de Pernambuco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kátia Monte-Silva, Doctor, Universidade Federal de Pernambuco
• ClinicalTrials.gov Identifier: NCT01877148
• Other Study ID Numbers: Parkinson_tDCS_rehabilitation
• First Posted: Jun 13, 2013
• Last Update Posted: May 15, 2015
• Last Verified: Jun 1, 2013

• Keywords provided by Kátia Monte-Silva, Doctor, Universidade Federal de Pernambuco: Parkinson, rehabilitation, tDCS
• Additional relevant MeSH terms: Parkinson Disease

Study Results

Participant Flow

Arm/Group Title	Physiotherapy + Anodal tDCS	Physiotherapy + Sham tDCS
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	6	6
COMPLETED	5	5
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Physiotherapy + Anodal tDCS	Physiotherapy + Sham tDCS	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	5	5	10
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	4 80%	1 20%	5 50%
>=65 years	1 20%	4 80%	5 50%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59 (9.27)	68.2 (11.75)	63.6 (10.51)
Sex: Female, Male (Count of Participants)
Female	3 60%	1 20%	4 40%
Male	2 40%	4 80%	6 60%
Region of Enrollment (participants) [Number]
Brazil	5 100%	5 100%	10 100%

Outcome Measures

1. Primary Outcome

Title	Change From Unified Parkinson´s Disease Rating Scale - UPDRS
Description	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
Time Frame	At baseline, after 1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physiotherapy + Anodal tDCS	Physiotherapy + Sham tDCS
Arm/Group Description	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	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
Measure Participants	5	5
Baseline	24 (12)	30 (23)
post 1 month	21.2 (11.12)	21.8 (14.0)

2. Secondary Outcome

Title	Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation
Time Frame	per sesssion: at baseline and after physical therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physiotherapy + Anodal tDCS	Physiotherapy + Sham tDCS
Arm/Group Description	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	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
Measure Participants	5	5
Baseline	1.01 (0.25)	1 (0.22)
post 1 month	1.35 (0.24)	1.15 (0.31)

3. Other Pre-specified Outcome

Title	Change From Parkinson Disease Quality of Life - PDQL
Description	Parkinson 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
Time Frame	at baseline, after 1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physiotherapy + Anodal tDCS	Physiotherapy + Sham tDCS
Arm/Group Description	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	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
Measure Participants	5	5
Baseline	112.8 (44.1)	117.2 (45.6)
post 1 month	120.2 (35.07)	125.8 (37.83)

4. Other Pre-specified Outcome

Title	Change From Jebsen-Taylor Hand Function Test - Jebsen Test
Description	The 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
Time Frame	At baseline, after 1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physiotherapy + Anodal tDCS	Physiotherapy + Sham tDCS
Arm/Group Description	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	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
Measure Participants	5	5
Baseline	106.36 (55.93)	90.63 (45.53)
post 1 month	86.62 (48.71)	81.29 (27.5)

Adverse Events

Time Frame	after tDCS
Adverse Event Reporting Description	Questionnaire of adverses effects
Arm/Group Title	Physiotherapy + Anodal tDCS		Physiotherapy + Sham tDCS
Arm/Group Description	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		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
All Cause Mortality
	Physiotherapy + Anodal tDCS		Physiotherapy + Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Physiotherapy + Anodal tDCS		Physiotherapy + Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Physiotherapy + Anodal tDCS		Physiotherapy + Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.