Transcranial Direct Current Stimulation (tDCS) and Parkinson's Disease

• Sponsor: University of Maryland, Baltimore (Other)
• Overall Status: Completed
• CT.gov ID: NCT01100762
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 17
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The use of low level electrical stimulation when applied over the head, also called transcranial direct current stimulation (tDCS), is being tested by several groups of researchers to see if tDCS can improve movements of persons with damage to the brain. The safety and potential benefits of tDCS to children or adults patients who are paralyzed because of brain damage are reported in the medical literature. In addition, some patients with Parkinson's disease (PD) experience improvement in memory and report better use of the hand after tDCS. The treatment requires putting electrodes (pads) over the head and sending very small amount of electrical current that the patient may feel as "little tingling". Application of tDCS takes 20 min. In this study we wish to test if tDCS application can improve stepping and walking ability of subjects with PD and if the improvement is the same as when walking on treadmill. We plan to test the subject's ability to step when pulled by a laboratory testing system and also test his/her walking ability. There will be 3 sessions 7 days apart. In the first session the subject will be tested then treated for 20 min with tDCS and then tested again. In the second session the subject will be tested then walk on a treadmill for 20 min then tested again. In the third session the subject will be tested then walk on the treadmill for 20 min while receiving also tDCS and tested one last time at the end of the session. Each session will take between 2 and 3 hours.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Device: Cranial Electric Stimulation (CES); Device: Treadmill; Device: CES and Treadmill	N/A

Detailed Description

Recent advances in non-invasive electrical stimulation technology including transcranial direct current stimulation (tDCS) have provided novel and low risk options to rehabilitate the impaired ability of the central nervous system (CNS) to process sensorimotor information. Furthermore, tDCS appears to enhance CNS connectivity and there is preliminary evidence indicating that patients with Parkinson's Disease (PD) may experience improvement in working memory, the Unified Parkinson's Disease Rating Scale, simple reaction time and the Purdue Pegboard test. tDCS is inexpensive, portable and available for repeated home use. It may provide long-lasting enhancement of cortical activity in part because tDCS is easy to administer frequently and to combine it with other rehabilitation approaches including posture and gait training. However to date, no study has examined quantitatively the effects of tDCS on posture control and walking ability in patients with PD. As a first step we plan to identify the immediate effects of tDCS, as well as the added value of tDCS to treadmill exercise training, to improve posture and gait of individuals with PD.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Can Transcranial Direct Current Stimulation (tDCS)Modulate Protective Stepping and Gait Performance of People With Parkinson's Disease
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Single Group 10 subjects with Parkinson's Disease receiving tPCS during the first session, treadmill walk, 7-10 days later (second session, and combined tPCS and treadmill 7-10 days week later (third session)

Device: Cranial Electric Stimulation (CES); We will follow the procedure described by several investigators as safe and effective. The participant will sit on a standard chair. Two commercially available surface electrodes will be embedded in an elastic head cup. Each electrode will be covered with a water soaked absorbent fabric. One positive (+) electrode will be placed over the primary motor cortex (M1) and pre-motor areas. One negative (-) electrode will be placed over the skin overlying the contra lateral supra-orbital region. The electrodes will be connected via 2 leads to a battery powered direct current stimulator. The stimulator will be programmed to deliver 0.975mA (peak 4mA) over 20 minutes.; Device: Treadmill; The participant will walk on a treadmill for 20 minutes at the individually self-selected velocity determined at baseline.; Device: CES and Treadmill; Participants will have a combined session with CES while walking on the treadmill for 20 minutes at the individually self-selected velocity determined at baseline.

Outcome Measures

Primary Outcome Measures

1. Stride Length [Data collection occurred before and immediately after each training session]

   Stride Length was measured in centimeters

2. Gait Velocity [Data collection occurred before and immediately after each training session]

   Gait Velocity was measured in meters per second

3. Cadence [Data collection occurred before and immediately after each training session]

   Cadence was measured in steps per minute

4. Number of Steps to Regain Balance [Data collection occurred before and immediately after each training session]

   Steps to regain balance were measured by the number of steps needed to recover standing balance. The steps were counted using a custom software of the motion capture system.

5. First Step Length [Data collection occurred before and immediately after each training session]

   First step length was measured in meters from the starting position of the foot to the maximum displacement of the foot after the first step. Measurements were taken separately for forward and backward first step.

6. First Step Velocity [Data collection occurred before and immediately after each training session]

   First step velocity was measured in meters per second

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of adult onset of PD

• A history of freezing of gait (FOG) as evidence by clinical assessment

• A stable regimen of anti-parkinsonian medications

• Ability to walk at least 10m without assistance

• Ability to walk on a treadmill for 20 minutes

• Personal weight of less than 500 Lb (because the suspension harness over the treadmill is limited to 500 Lb

• Stage 3 of the Hoehn and Yahr disability scale

• A score of >24 on the Mini Mental State Examination

Exclusion Criteria:

• Evidence of any clinically significant functional impairment related to cardiovascular, pulmonary, metabolic, other neurologic or musculoskeletal disease criterial that would preclude participation in training

• Any medical condition that might require other medical or surgical treatment during the study period

• A history of brain surgery or placement of a deep brain stimulator

• Dyskinesias > grade 2 on the Unified Parkinson's Disease Rating Scale (UPDRS)

• Any uncorrected vision or hearing problems that may limit daily activities or communication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PTRS Research Lab	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• University of Maryland, Baltimore

Investigators

• Principal Investigator: Gad Alon, PhD, PT, University of Maryland, Baltimore
• Principal Investigator: Mark W Rogers, PhD, PT, University of Maryland, Baltimore
• Principal Investigator: Lisa Shulman, MD, Univeristy of Maryland, Baltimore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gad Alon, Associate Professor, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT01100762
• Other Study ID Numbers: HP-00040670
• First Posted: Apr 9, 2010
• Last Update Posted: Oct 30, 2019
• Last Verified: Oct 1, 2019

• Keywords provided by Gad Alon, Associate Professor, University of Maryland, Baltimore: Parkinson's Disease; Cranial Electric Stimulation; Gait
• Additional relevant MeSH terms: Parkinson Disease

Study Results

Participant Flow

Recruitment Details	Study subjects were recruited via phone call or in person from the University of Maryland, Baltimore's Department of Neurology and the Department of Physical Therapy & Rehabilitation Sciences databases. The recruitment period was from January 2010 through June 2011.

Arm/Group Title	Single Group
Arm/Group Description	In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes. In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes. In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Single Group
Arm/Group Description	In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes. In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes. In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 10%
>=65 years	9 90%
Sex: Female, Male (Count of Participants)
Female	3 30%
Male	7 70%

Outcome Measures

1. Primary Outcome

Title	Stride Length
Description	Stride Length was measured in centimeters
Time Frame	Data collection occurred before and immediately after each training session

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cranial Electric Stimulation (CES)	Treadmill	CES and Treadmill
Arm/Group Description	In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.	In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.	In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
Measure Participants	10	10	10
Pre Intervention	102.10 (24.40)	112.30 (27.30)	109.80 (25.40)
Post Intervention	111.20 (22.10)	110.40 (26.40)	110.20 (26.70)

2. Primary Outcome

Title	Gait Velocity
Description	Gait Velocity was measured in meters per second
Time Frame	Data collection occurred before and immediately after each training session

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cranial Electric Stimulation (CES)	Treadmill	CES and Treadmill
Arm/Group Description	In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.	In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.	In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
Measure Participants	10	10	10
Pre Intervention	0.90 (0.23)	102.10 (27.70)	100.00 (24.10)
Post Intervention	0.985 (0.19)	97.90 (25.80)	98.30 (27.00)

3. Primary Outcome

Title	Cadence
Description	Cadence was measured in steps per minute
Time Frame	Data collection occurred before and immediately after each training session

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cranial Electric Stimulation (CES)	Treadmill	CES and Treadmill
Arm/Group Description	In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.	In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.	In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
Measure Participants	10	10	10
Pre Intervention	106.20 (11.60)	109.30 (10.80)	110.00 (11.40)
Post Intervention	107.00 (9.80)	107.00 (12.70)	107.20 (10.40)

4. Primary Outcome

Title	Number of Steps to Regain Balance
Description	Steps to regain balance were measured by the number of steps needed to recover standing balance. The steps were counted using a custom software of the motion capture system.
Time Frame	Data collection occurred before and immediately after each training session

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cranial Electric Stimulation (CES)	Treadmill	CES and Treadmill
Arm/Group Description	In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.	In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.	In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
Measure Participants	10	10	10
Pre Intervention	2.22 (1.15)	2.00 (0.90)	2.28 (1.31)
Post Intervention	2.02 (1.02)	2.10 (1.01)	1.94 (1.05)

5. Primary Outcome

Title	First Step Length
Description	First step length was measured in meters from the starting position of the foot to the maximum displacement of the foot after the first step. Measurements were taken separately for forward and backward first step.
Time Frame	Data collection occurred before and immediately after each training session

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cranial Electric Stimulation (CES)	Treadmill	CES and Treadmill
Arm/Group Description	In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.	In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.	In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
Measure Participants	10	10	10
Pre Intervention	0.340 (0.119)	0.333 (0.144)	0.316 (0.136)
Post Intervention	0.317 (0.126)	0.353 (0.151)	0.326 (0.125)

6. Primary Outcome

Title	First Step Velocity
Description	First step velocity was measured in meters per second
Time Frame	Data collection occurred before and immediately after each training session

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cranial Electric Stimulation (CES)	Treadmill	CES and Treadmill
Arm/Group Description	In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.	In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.	In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
Measure Participants	10	10	10
Pre Intervention	0.859 (0.274)	0.839 (0.369)	0.767 (0.298)
Post Intervention	0.807 (0.342)	0.873 (0.362)	0.799 (0.275)

Adverse Events

Time Frame	3 weeks
Arm/Group Title	Single Group
Arm/Group Description	In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes. In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes. In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
All Cause Mortality
	Single Group
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Single Group
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Single Group
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

The absence of a placebo CES Limiting the stimulation to only one region of interest (Right M1) Non-random order of intervention CES for only one 20 minute session

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.