Parkinson's DiseaseNCT01100762
Transcranial Direct Current Stimulation (tDCS) and Parkinson's Disease
A study testing Cranial Electric Stimulation (CES), Treadmill and CES and Treadmill in people with Parkinson's Disease, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Cranial Electric Stimulation (CES), Treadmill and CES and Treadmill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Transcranial Direct Current Stimulation (tDCS)Modulate Protective Stepping and Gait Performance of People With Parkinson's Disease
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Cranial Electric Stimulation (CES), Treadmill, CES and Treadmill
- Keywords
- Parkinson's Disease, Cranial Electric Stimulation, Gait
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial Electric Stimulation (CES)Device
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.
TreadmillDevice
The participant will walk on a treadmill for 20 minutes at the individually self-selected velocity determined at baseline.
CES and TreadmillDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Experimental | 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) Receives: Device: Cranial Electric Stimulation (CES); Device: Treadmill; Device: CES and Treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stride Length
Stride Length was measured in centimeters
Measured: Data collection occurred before and immediately after each training session
Gait Velocity
Gait Velocity was measured in meters per second
Measured: Data collection occurred before and immediately after each training session
Cadence
Cadence was measured in steps per minute
Measured: Data collection occurred before and immediately after each training session
Number of Steps to Regain Balance
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.
Measured: Data collection occurred before and immediately after each training session
First Step Length
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.
Measured: Data collection occurred before and immediately after each training session
First Step Velocity
First step velocity was measured in meters per second
Measured: Data collection occurred before and immediately after each training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gad Alon, University of Maryland, Baltimore
- Investigators
- Gad Alon, PhD, PT, Principal investigator, University of Maryland, BaltimoreMark W Rogers, PhD, PT, Principal investigator, University of Maryland, BaltimoreLisa Shulman, MD, Principal investigator, Univeristy of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100762
- Sponsor's protocol ID
- HP-00040670
- Status last verified
- Oct 2019
- First submitted
- 19 Mar 2010
- Last updated
- 30 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Transcranial Direct Current Stimulation (tDCS)Modulate Protective Stepping and Gait Performance of People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01100762
- Acronym / sponsor ID
- HP-00040670
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Cranial Electric Stimulation, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 9 Apr 2010 (estimated)
- Results
- Posted 7 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | Experimental | Device: Cranial Electric Stimulation (CES), Device: Treadmill, Device: CES and Treadmill10 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) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Single Group |
| TreadmillThe participant will walk on a treadmill for 20 minutes at the individually self-selected velocity determined at baseline. | Device | Single Group |
| CES and TreadmillParticipants will have a combined session with CES while walking on the treadmill for 20 minutes at the individually self-selected velocity determined at baseline. | Device | Single Group |
Primary outcome
Stride Length
Time frame: Data collection occurred before and immediately after each training session
Stride Length was measured in centimeters
Gait Velocity
Time frame: Data collection occurred before and immediately after each training session
Gait Velocity was measured in meters per second
Cadence
Time frame: Data collection occurred before and immediately after each training session
Cadence was measured in steps per minute
Number of Steps to Regain Balance
Time frame: 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.
First Step Length
Time frame: 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.
First Step Velocity
Time frame: Data collection occurred before and immediately after each training session
First step velocity was measured in meters per second
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gad Alon, PhD, PT principal investigator
University of Maryland, Baltimore
Mark W Rogers, PhD, PT principal investigator
University of Maryland, Baltimore
Lisa Shulman, MD principal investigator
Univeristy of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranial Electric Stimulation (CES), Treadmill and CES and Treadmill in people with Parkinson's Disease, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stride Length (time frame: Data collection occurred before and immediately after each training session). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.