Parkinson's DiseasePhase 1NCT00029276
Magnetic Stimulation for Parkinson Disease
A Phase 1 study testing Prefrontal transcranial magnetic brain stimulation in people with Parkinson's Disease and Depression, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
During transcranial magnetic stimulation (TMS), a magnetic coil is placed on the front part of the head. Electric current passes through the coil in brief pulses. Magnetism from the current produces a separate, small electric current inside the brain, which activates brain cells below the coil. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson's Disease, Depression
- What is being tested?
- Prefrontal transcranial magnetic brain stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to Apr 2005
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of idiopathic Parkinson's Disease and meet DSM-IV criteria for Major Depressive Episode, severe, with or without psychotic features, or for Mood Disorder secondary to PD with major depression-like episode.
- Have demonstrated an inadequate clinical response to at least one antidepressant medication in adequate dosage for at least six weeks, or an adverse event requiring discontinuation.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Magnetic Stimulation For Treatment Of Depression In Parkinson's Disease
During transcranial magnetic stimulation (TMS), a magnetic coil is placed on the front part of the head. Electric current passes through the coil in brief pulses. Magnetism from the current produces a separate, small electric current inside the brain, which activates brain cells below the coil. This treatment may result in decreased depression and improved Parkinson's disease symptoms.
Read the detailed description
The major aim of this study is to carry out a sequential Phase I trial of prefrontal transcranial magnetic brain stimulation (TMS) and electroconvulsive therapy (ECT) in patients with Parkinson's disease (PD) and severe depression. Depression complicates PD in up to 50% of cases, leading to further deterioration of motor performance and quality of life; but antidepressant medication fails or produces intolerable side effects in 25-30% of patients. Case reports and uncontrolled trials suggest that ECT is effective in ameliorating simultaneously the mood and motor symptoms of PD. Only a few small studies of ECT in PD have been prospective or randomized, the assessment protocols have been limited, and the results have been variable. TMS is a new, promising, alternative treatment for refractory depression, which appears to be easier and safer than ECT. Requiring no hospitalization, anesthesia, or recovery time, TMS is now being investigated as an alternative therapy for mood disorders. TMS has not been studied in depressed patients with PD or in other serious central nervous system diseases.
This study extends our past and present research in PD, depression, ECT, and TMS. We will comprehensively evaluate the effects of left prefrontal TMS on mood, motor, and neuropsychological function, together with quality of life indices in depressed PD patients. All patients will initially receive treatment with TMS. Those who fail to benefit will proceed to ECT. Comprehensive evaluation will be continued for another eight weeks in both the TMS-only and ECT groups. The key issues addressed by these studies include: (1) the potential benefit of TMS on mood and movement in depressed PD patients, and (2) the tightness of the association between mood and motor function after TMS and ECT. Overall, these studies will provide important preliminary data on the relationships among mood, cognitive and motor function in PD, and their influence on quality of life. The results will help in directing future applications of TMS as an alternative therapy for brain disorders, and will further elucidate the relative benefits of both TMS and ECT in depressed PD patients. A positive effect from TMS should be an impetus towards randomized, placebo-controlled trials.
- Conditions
- Parkinson's Disease, Depression
- Being tested
- Prefrontal transcranial magnetic brain stimulation
- Keywords
- Parkinson's, Depression, Magnetic Stimulation
- Medical subject headings
- Parkinson Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prefrontal transcranial magnetic brain stimulationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2002 (estimated)
- Study startAug 2000
- Study completionApr 2005
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Charles Epstein, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029276
- Sponsor's protocol ID
- R01AT000610-01
- Status last verified
- Aug 2006
- First submitted
- 9 Jan 2002
- Last updated
- 18 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation For Treatment Of Depression In Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00029276
- Acronym / sponsor ID
- R01AT000610-01
- Conditions
- Parkinson's Disease, Depression
- Keywords
- Parkinson's, Depression, Magnetic Stimulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Aug 2000
- Study completion
- Apr 2005
- First posted
- 10 Jan 2002 (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.
During transcranial magnetic stimulation (TMS), a magnetic coil is placed on the front part of the head. Electric current passes through the coil in brief pulses. Magnetism from the current produces a separate, small electric current inside the brain, which activates brain cells below the coil. This treatment may result in decreased depression and improved Parkinson's disease symptoms.
Detailed description
The major aim of this study is to carry out a sequential Phase I trial of prefrontal transcranial magnetic brain stimulation (TMS) and electroconvulsive therapy (ECT) in patients with Parkinson's disease (PD) and severe depression. Depression complicates PD in up to 50% of cases, leading to further deterioration of motor performance and quality of life; but antidepressant medication fails or produces intolerable side effects in 25-30% of patients. Case reports and uncontrolled trials suggest that ECT is effective in ameliorating simultaneously the mood and motor symptoms of PD. Only a few small studies of ECT in PD have been prospective or randomized, the assessment protocols have been limited, and the results have been variable. TMS is a new, promising, alternative treatment for refractory depression, which appears to be easier and safer than ECT. Requiring no hospitalization, anesthesia, or recovery time, TMS is now being investigated as an alternative therapy for mood disorders. TMS has not been studied in depressed patients with PD or in other serious central nervous system diseases.
This study extends our past and present research in PD, depression, ECT, and TMS. We will comprehensively evaluate the effects of left prefrontal TMS on mood, motor, and neuropsychological function, together with quality of life indices in depressed PD patients. All patients will initially receive treatment with TMS. Those who fail to benefit will proceed to ECT. Comprehensive evaluation will be continued for another eight weeks in both the TMS-only and ECT groups. The key issues addressed by these studies include: (1) the potential benefit of TMS on mood and movement in depressed PD patients, and (2) the tightness of the association between mood and motor function after TMS and ECT. Overall, these studies will provide important preliminary data on the relationships among mood, cognitive and motor function in PD, and their influence on quality of life. The results will help in directing future applications of TMS as an alternative therapy for brain disorders, and will further elucidate the relative benefits of both TMS and ECT in depressed PD patients. A positive effect from TMS should be an impetus towards randomized, placebo-controlled trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have a diagnosis of idiopathic Parkinson's Disease and meet DSM-IV criteria for Major Depressive Episode, severe, with or without psychotic features, or for Mood Disorder secondary to PD with major depression-like episode.
- Have demonstrated an inadequate clinical response to at least one antidepressant medication in adequate dosage for at least six weeks, or an adverse event requiring discontinuation.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Prefrontal transcranial magnetic brain stimulation | Procedure or surgery | – |
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 18 Aug 2006.
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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.
Charles Epstein, MD principal investigator
Emory 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 Prefrontal transcranial magnetic brain stimulation in people with Parkinson's Disease and Depression, run by National Center for Complementary and Integrative Health (NCCIH) 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 0 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 18 Aug 2006. 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.
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 18 Aug 2006.