Parkinson's DiseaseNCT00431366
Sequence Effect in Parkinson's Disease
An observational study of Parkinson's Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will explore sequence effect, a fatigue or tiredness commonly seen in patients with Parkinson's disease after they have been doing the same thing for a while. The study will use a new device called a modified peg board test (see description below) to measure whether antiparkinsonian medications… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2007to 24 Dec 2008
- Phase
- Observational
- 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
- Age 18 years and older.
- Right hand dominant (Edinburgh Handedness Quotient greater than 60).
- Able to provide consent for the protocol.
- Hoehn \& Yahr stages: I - III (de novo PD patients); II - IV (advanced PD patients).
- Never treated with antiparkinsonian medications (de novo PD patients).
- Able to go off of antiparkinsonian medications for a minimum 14 hours (advanced PD patients), i.e. overnight withdrawal until after the experiments are completed here at NIH.
Who cannot join
- Patients with any other medical, surgical, neurological or psychiatric conditions except PD.
- Patients with known symptomatic wearing off.
- Pregnant women.
- Concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs other than antiparkinsonian agents that could lower the seizure threshold.
- Persons with surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), intracardiac lines that may pose a physical hazard during magnetic stimulation will also be excluded.
- Patients with history of seizure disorder or epilepsy.
- Subjects without the capacity to give informed consent.
- If participation in the study would, in the opinion of the investigators, cause undue risk or stress for reasons such as excessive fatigue, general frailty, or excessive apprehension.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: The Characteristics of Sequence Effect in de Novo and Advanced Parkinson's Disease
This study will explore sequence effect, a fatigue or tiredness commonly seen in patients with Parkinson's disease after they have been doing the same thing for a while. The study will use a new device called a modified peg board test (see description below) to measure whether antiparkinsonian medications (levodopa/carbidopa or dopamine) and repetitive transcranial magnetic stimulation (rTMS, see description below) of the brain can improve the symptoms of sequence effect.
Patients with early-stage Parkinson's disease who have never taken antiparkinsonian medications and patients with advanced disease may be eligible for this study. Candidates must be 18 years of age or older and right-handed.
Read more
Participants have five visits to the NIH Clinical Center as follows:
- Visit 1 (baseline): Patients have a neurological examination, including brief cognitive function tests, a rating for depression, and two types of ratings for fatigue severity.
- Visits 2 through 5 (experimental sessions): Patients who have been taking antiparkinson medication for a long time are asked to not take their medication for about 12 hours (overnight withdrawal) before visits 2 through 5. They are off medication for about 14 hours total (until after the experiments are done). Patients may be admitted to the NIH Clinical Center for the overnight drug withdrawal if necessary. At the start of each session, participants are given either levodopa/carbidopa tablets or placebo (tablets identical in appearance but with no active medication). They perform the modified pegboard test before medication, after medication, and after brain stimulation with rTMS. During two of the sessions, they receive actual brain stimulation, and during the other two sessions they receive sham stimulation, which does not actually stimulate the brain.
The modified pegboard test is a computer-based machine with eight pegs. Subjects transfer each peg from a line of holes on the right side to a line of holes on the left side using their right hand and moving as quickly as possible. After they finish moving all pegs to the left line of holes, they wait for a beep and then transfer the pegs from left line to right line of holes. They do this six times, three times with their right hand and three times with their left.
rTMS involves repeated magnetic pulses delivered in trains or short bursts of impulses. A brief electrical current is passed through a wire coil held on the scalp. The current creates a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in muscles of the face, arm or leg. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions. The effect of TMS on the muscles is detected with small metal disk electrodes taped onto the skin of the right hand. Subjects receive four rTMS blocks per 10 minutes. Each block consists of a total of 375 pulses.
Read the detailed description
Objective:
The long-term goal is to provide new insight into the effect of long-lasting sequence movements (sequence effect) by investigating de novo and advanced Parkinson's disease (PD) patients with an objective measurement. Our central hypothesis is that sequence effect is caused by depressed excitability of the motor cortex, and is partially associated with dopaminergic deficiency. Specifically, the aims of this study are to show that the sequence effect is more severe in advanced PD than in de novo PD and to evaluate the extent of improvement by levodopa and repetitive transcranial magnetic stimulation (rTMS) and to show the correlation of fatigue.
Study Population:
Twelve de novo PD patients and 12 age- and sex-matched advanced PD patients.
Design:
We will compare objectively measured sequence effect with a modified Purdue pegboard, a computer-based device, in de novo and advanced PD patients. The modified Purdue Pegboard will detect start and stop times for individual peg insertion and for the task in its entirety. The sequence effect in this protocol is detected by the progressive changes of time intervals per peg insertion during the testing session. A time interval is defined as the period between the start and stop times for individual peg insertion. We will conduct a placebo-controlled, four-way crossover study to determine the beneficial effect of levodopa and rTMS on the sequence effect in de novo and advanced PD. The four interventions are: levodopa and rTMS; levodopa and sham; placebo and rTMS; and placebo and sham. A replicated 4 periods and four intervention-Latin Square design will be used for the crossover design.
Outcome Measures:
The primary outcome will be the difference between two time intervals, individual 1st and 8th peg insertion time, in 1st run (8-consecutive peg insertions) with right hand, which will be compared between de novo PD and advanced PD. The secondary outcomes are: (a) the difference in progressive changes of six time values for six runs; (b) the beneficial effect of levodopa and rTMS on sequence effect; and (c) correlation between the time intervals of first and eighth peg insertion and the scores of two subjective fatigue scales, i.e., Fatigue Severity Scale (FSS) and Multidimensional Fatigue Inventory (MFI).
- Conditions
- Parkinson's Disease
- Keywords
- Fatigue, Repetitive TMS (rTMS), Parkinson's Disease, Peg Board Test, Levodopa, Parkinson Disease, PD
- Medical subject headings
- Parkinson Disease, Fatigue
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2007 (estimated)
- Study start1 Feb 2007
- Study completion24 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431366
- Sponsor's protocol ID
- 070088
- Other IDs
- 07-N-0088
- Status last verified
- 24 Dec 2008
- First submitted
- 2 Feb 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Patenaude H, Gelinas C, Vandal S, Fillion L. [Elaboration of a conceptual frame to explain fatigue secondary to a health difficulty and implications for nursing practice]. Rech Soins Infirm. 2002 Sep;(70):66-81. French.
PubMed 12385192Abe K, Takanashi M, Yanagihara T, Sakoda S. Pergolide mesilate may improve fatigue in patients with Parkinson's disease. Behav Neurol. 2001-2002;13(3-4):117-21. doi: 10.1155/2002/473140.
PubMed 12446951Agostino R, Berardelli A, Curra A, Accornero N, Manfredi M. Clinical impairment of sequential finger movements in Parkinson's disease. Mov Disord. 1998 May;13(3):418-21. doi: 10.1002/mds.870130308.
PubMed 9613731
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Characteristics of Sequence Effect in de Novo and Advanced Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00431366
- Acronym / sponsor ID
- 070088
- Conditions
- Parkinson's Disease
- Keywords
- Fatigue, Repetitive TMS (rTMS), Parkinson's Disease, Peg Board Test, Levodopa, Parkinson Disease, PD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 1 Feb 2007
- Study completion
- 24 Dec 2008
- First posted
- 5 Feb 2007 (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 study will explore sequence effect, a fatigue or tiredness commonly seen in patients with Parkinson's disease after they have been doing the same thing for a while. The study will use a new device called a modified peg board test (see description below) to measure whether antiparkinsonian medications (levodopa/carbidopa or dopamine) and repetitive transcranial magnetic stimulation (rTMS, see description below) of the brain can improve the symptoms of sequence effect.
Patients with early-stage Parkinson's disease who have never taken antiparkinsonian medications and patients with advanced disease may be eligible for this study. Candidates must be 18 years of age or older and right-handed.
Participants have five visits to the NIH Clinical Center as follows:
- Visit 1 (baseline): Patients have a neurological examination, including brief cognitive function tests, a rating for depression, and two types of ratings for fatigue severity.
- Visits 2 through 5 (experimental sessions): Patients who have been taking antiparkinson medication for a long time are asked to not take their medication for about 12 hours (overnight withdrawal) before visits 2 through 5. They are off medication for about 14 hours total (until after the experiments are done). Patients may be admitted to the NIH Clinical Center for the overnight drug withdrawal if necessary. At the start of each session, participants are given either levodopa/carbidopa tablets or placebo (tablets identical in appearance but with no active medication). They perform the modified pegboard test before medication, after medication, and after brain stimulation with rTMS. During two of the sessions, they receive actual brain stimulation, and during the other two sessions they receive sham stimulation, which does not actually stimulate the brain.
The modified pegboard test is a computer-based machine with eight pegs. Subjects transfer each peg from a line of holes on the right side to a line of holes on the left side using their right hand and moving as quickly as possible. After they finish moving all pegs to the left line of holes, they wait for a beep and then transfer the pegs from left line to right line of holes. They do this six times, three times with their right hand and three times with their left.
rTMS involves repeated magnetic pulses delivered in trains or short bursts of impulses. A brief electrical current is passed through a wire coil held on the scalp. The current creates a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in muscles of the face, arm or leg. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions. The effect of TMS on the muscles is detected with small metal disk electrodes taped onto the skin of the right hand. Subjects receive four rTMS blocks per 10 minutes. Each block consists of a total of 375 pulses.
Detailed description
Objective:
The long-term goal is to provide new insight into the effect of long-lasting sequence movements (sequence effect) by investigating de novo and advanced Parkinson's disease (PD) patients with an objective measurement. Our central hypothesis is that sequence effect is caused by depressed excitability of the motor cortex, and is partially associated with dopaminergic deficiency. Specifically, the aims of this study are to show that the sequence effect is more severe in advanced PD than in de novo PD and to evaluate the extent of improvement by levodopa and repetitive transcranial magnetic stimulation (rTMS) and to show the correlation of fatigue.
Study Population:
Twelve de novo PD patients and 12 age- and sex-matched advanced PD patients.
Design:
We will compare objectively measured sequence effect with a modified Purdue pegboard, a computer-based device, in de novo and advanced PD patients. The modified Purdue Pegboard will detect start and stop times for individual peg insertion and for the task in its entirety. The sequence effect in this protocol is detected by the progressive changes of time intervals per peg insertion during the testing session. A time interval is defined as the period between the start and stop times for individual peg insertion. We will conduct a placebo-controlled, four-way crossover study to determine the beneficial effect of levodopa and rTMS on the sequence effect in de novo and advanced PD. The four interventions are: levodopa and rTMS; levodopa and sham; placebo and rTMS; and placebo and sham. A replicated 4 periods and four intervention-Latin Square design will be used for the crossover design.
Outcome Measures:
The primary outcome will be the difference between two time intervals, individual 1st and 8th peg insertion time, in 1st run (8-consecutive peg insertions) with right hand, which will be compared between de novo PD and advanced PD. The secondary outcomes are: (a) the difference in progressive changes of six time values for six runs; (b) the beneficial effect of levodopa and rTMS on sequence effect; and (c) correlation between the time intervals of first and eighth peg insertion and the scores of two subjective fatigue scales, i.e., Fatigue Severity Scale (FSS) and Multidimensional Fatigue Inventory (MFI).
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years and older.
- Right hand dominant (Edinburgh Handedness Quotient greater than 60).
- Able to provide consent for the protocol.
- Hoehn \& Yahr stages: I - III (de novo PD patients); II - IV (advanced PD patients).
- Never treated with antiparkinsonian medications (de novo PD patients).
Key exclusion criteria (8 listed)
- Patients with any other medical, surgical, neurological or psychiatric conditions except PD.
- Patients with known symptomatic wearing off.
- Pregnant women.
- Concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs other than antiparkinsonian agents that could lower the seizure threshold.
- Persons with surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), intracardiac lines that may pose a physical hazard during magnetic stimulation will also be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 12385192Patenaude H, Gelinas C, Vandal S, Fillion L. [Elaboration of a conceptual frame to explain fatigue secondary to a health difficulty and implications for nursing practice]. Rech Soins Infirm. 2002 Sep;(70):66-81. French.
- Background: PubMed 12446951Abe K, Takanashi M, Yanagihara T, Sakoda S. Pergolide mesilate may improve fatigue in patients with Parkinson's disease. Behav Neurol. 2001-2002;13(3-4):117-21. doi: 10.1155/2002/473140.
- Background: PubMed 9613731Agostino R, Berardelli A, Curra A, Accornero N, Manfredi M. Clinical impairment of sequential finger movements in Parkinson's disease. Mov Disord. 1998 May;13(3):418-21. doi: 10.1002/mds.870130308.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 6 inclusion and 8 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 2 Jul 2017. 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00431366, which also lists 3 linked publications.
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 2 Jul 2017.