Parkinson's DiseasePhase 1NCT02104401
Open Label Treatment With tDCS for Parkinson's and Related Disorders for Improvement of Speech, Gait and Mood
A Phase 1 study testing tDCS in people with Parkinson's Disease, run by Georgetown University at 1 site in United States.
Trial summary
This research will help us to understand whether transcranial direct current stimulation (tDCS) can safely improve recovery of speech and language abilities, gait , and mood in people with Parkinson's disease and related disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- tDCS
- 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
- Oct 2013to Mar 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease or a related disorder (e.g. Multiple Systems Atrophy) as diagnosed by a neurologist specializing in Movement Disorders
- Age >= 18 years
Who cannot join
- Skull defect at or near site of tDCS delivery.
- History of a significant stroke or traumatic brain injury.
- History of other brain conditions that could impact interpretation of results (such as MS, brain tumor, encephalitis).
- Presence of implanted electrical or metallic devices in the head or body (examples include cardiac pacemakers or defibrillators, Baclofen pumps, deep brain stimulators, ventricular shunts with metallic parts, vagus nerve stimulators)
- Presence of ferrous metal in the head (except titanium; for instance shrapnel)
- History of psychiatric disease requiring hospitalization, electroconvulsive therapy, or ongoing medication use (other than common antidepressants)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
Official title: Pilot Study: Open Label Treatment With tDCS for Parkinson's and Related Disorders for Improvement of Speech, Gait and Mood
This research will help us to understand whether transcranial direct current stimulation (tDCS) can safely improve recovery of speech and language abilities, gait , and mood in people with Parkinson's disease and related disorders. Some of the disorders that will be studied to understand if tDCS can be useful include Parkinson's Disease, Multi-System Atrophy (MSA) and progressive supranuclear palsy (PSP).
- Conditions
- Parkinson's Disease
- Being tested
- tDCS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
tDCS will be applied with a Soterix CT tDCS Device with a HD-tDCS 4x1 Multi-Channel Stimulation Interface. During stimulation, a low level of constant DC electrical current (1-2 mA) will be applied via the electrodes. Current will be ramped up over 10-60 seconds, and typically causes very mild tingling and itching sensations. The current will be applied for no more than 20 minutes per session, at which time the current is ramped down over 10-60 seconds. Subjects will be seated in a chair throughout tDCS administration. Subjects will receive tDCS 5 days/week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| tDCS | Experimental | tDCS will be applied with a Soterix CT tDCS Device with a HD-tDCS 4x1 Multi-Channel Stimulation Interface. During stimulation, a low level of constant DC electrical current (1-2 mA) will be applied via the electrodes. Current will be ramped up over 10-60 seconds, and typically causes very mild tingling and itching sensations. The current will be applied for no more than 20 minutes per session, at which time the current is ramped down over 10-60 seconds. Subjects will be seated in a chair throughout tDCS administration. Subjects will receive tDCS 5 days/week for 4 weeks. Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Motor and Speech Symptoms of Parkinson's Disease or Related Disorders
We will perform an assessment of motor function using Part III of the Unified Parkinson's Disease Rating Scale (UPDRS), timed test of gait, and patient self-assessment. Speech functions will be assessed with sentence repetition,evaluation of spontaneous speech, and other standard language tests. The assessment will also include other measures and questionnaires (e.g. Bech Depression Inventory) to be filled out by the patient and his/her family.
Measured: 16 weeks
Secondary outcomes (1)
Improvement of Neuropsychiatric Symptoms of Parkinson's Disease or Related Disorders
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startOct 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Ferrell Family Charitable Foundation
- Responsible party
- Sponsor
- Investigators
- Fernando Pagan, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104401
- Sponsor's protocol ID
- 00000
- Status last verified
- Aug 2014
- First submitted
- 2 Apr 2014
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Open Label Treatment With tDCS for Parkinson's and Related Disorders for Improvement of Speech, Gait and Mood
- ClinicalTrials.gov ID
- NCT02104401
- Acronym / sponsor ID
- 00000
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Ferrell Family Charitable Foundation
- Study start
- Oct 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research will help us to understand whether transcranial direct current stimulation (tDCS) can safely improve recovery of speech and language abilities, gait , and mood in people with Parkinson's disease and related disorders. Some of the disorders that will be studied to understand if tDCS can be useful include Parkinson's Disease, Multi-System Atrophy (MSA) and progressive supranuclear palsy (PSP).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tDCS | Experimental | Device: tDCStDCS will be applied with a Soterix CT tDCS Device with a HD-tDCS 4x1 Multi-Channel Stimulation Interface. During stimulation, a low level of constant DC electrical current (1-2 mA) will be applied via the electrodes. Current will be ramped up over 10-60 seconds, and typically causes very mild tingling and itching sensations. The current will be applied for no more than 20 minutes per session, at which time the current is ramped down over 10-60 seconds. Subjects will be seated in a chair throughout tDCS administration. Subjects will receive tDCS 5 days/week for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Parkinson's disease or a related disorder (e.g. Multiple Systems Atrophy) as diagnosed by a neurologist specializing in Movement Disorders
- Age >= 18 years
Key exclusion criteria (7 listed)
- Skull defect at or near site of tDCS delivery.
- History of a significant stroke or traumatic brain injury.
- History of other brain conditions that could impact interpretation of results (such as MS, brain tumor, encephalitis).
- Presence of implanted electrical or metallic devices in the head or body (examples include cardiac pacemakers or defibrillators, Baclofen pumps, deep brain stimulators, ventricular shunts with metallic parts, vagus nerve stimulators)
- Presence of ferrous metal in the head (except titanium; for instance shrapnel)
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 |
|---|---|---|
| tDCStDCS will be applied with a Soterix CT tDCS Device with a HD-tDCS 4x1 Multi-Channel Stimulation Interface. During stimulation, a low level of constant DC electrical current (1-2 mA) will be applied via the electrodes. Current will be ramped up over 10-60 seconds, and typically causes very mild tingling and itching sensations. The current will be applied for no more than 20 minutes per session, at which time the current is ramped down over 10-60 seconds. Subjects will be seated in a chair throughout tDCS administration. Subjects will receive tDCS 5 days/week for 4 weeks. | Device | tDCS |
Primary outcome
Improvement of Motor and Speech Symptoms of Parkinson's Disease or Related Disorders
Time frame: 16 weeks
We will perform an assessment of motor function using Part III of the Unified Parkinson's Disease Rating Scale (UPDRS), timed test of gait, and patient self-assessment. Speech functions will be assessed with sentence repetition,evaluation of spontaneous speech, and other standard language tests. The assessment will also include other measures and questionnaires (e.g. Bech Depression Inventory) to be filled out by the patient and his/her family.
1 secondary outcome
Improvement of Neuropsychiatric Symptoms of Parkinson's Disease or Related Disorders
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
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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.
Fernando Pagan, MD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tDCS in people with Parkinson's Disease, run by Georgetown University 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 2 inclusion and 7 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 20 Aug 2014. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement of Motor and Speech Symptoms of Parkinson's Disease or Related Disorders (time frame: 16 weeks). 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 20 Aug 2014.