Multiple SclerosisrTMS in MSNCT01106365
Repetitive Deep Transcranial Magnetic Stimulation in Multiple Sclerosis
A study testing H-coil (Repetitive deep transcranial magnetic stimulation) in people with Multiple Sclerosis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Multiple sclerosis (MS) is a chronic-inflammatory autoimmune central nervous system disorder and a leading cause of neurological disability in younger adults in Western countries. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- H-coil (Repetitive deep transcranial magnetic stimulation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2010to Dec 2012
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female patients with clinically definite MS according to Polman
- Age 18 to 60
- EDSS 0 to 6
- Relapse-free > 30 days prior to inclusion
- Stable immunomodulatory or immunosuppressive therapy or treatment-naïve for > 3 months prior to inclusion
- In case of treatment with antidepressants: stable therapy > 3 months
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- A score of ≥ 4 on the FSS (fatigue severity scale)8 or
- A score of ≥ 12 on the Beck Depression Inventory (BDI)
- Highly effective methods of birth control for females
Who cannot join
- Personal or family history of epilepsy, brain tumor, brain injury
- History of metallic particles in the eye or head outside the mouth
- Cardiac pacemakers, implanted neurostimulators, cochlear implants, implanted medication pumps
- History of drug or alcohol abuse
- Pregnancy
- Relapse of MS < 30 days prior to inclusion
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- I.v. corticosteroid treatment < 30 days prior to inclusion
- Change of immunomodulatory therapy < 30 days prior to inclusion
- Change of antidepressant therapy < 3 months prior to inclusion
- Comedication with neuroleptics and tricyclic antidepressants (amitriptyline etc.) during the entire study
- patients with increased intracranial pressure (which lowers seizure threshold)
- intracardiac lines
- significant heart disease
- bipolar disorder
- history of stroke or other brain lesions
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charite University Berlin (NeuroCure Clinical Research Center NCRC)
Berlin, 10117
About this study
Official title: Repetitive Deep Transcranial Magnetic Stimulation in Multiple Sclerosis - A Pilot Study to Evaluate Safety and Efficacy of Deep rTMS on Fatigue and Depressivity in Patients With Multiple Sclerosis
Multiple sclerosis (MS) is a chronic-inflammatory autoimmune central nervous system disorder and a leading cause of neurological disability in younger adults in Western countries. Besides "classic" neurological symptoms both depressivity and fatigue are among the most frequent symptoms in MS, affecting up to 90% of patients at onset or during the course of the disease. Neither are the psychological and immunological backgrounds of both well understood, nor are there numerous controlled therapeutic trials which would offer convincing treatment options for fatigue and depressivity in MS.
Transcranial magnetic stimulation (TMS) has been frequently used to investigate altered hemispheric and inter-hemispheric connectivity in MS. Recently, first therapeutic trials have been performed to address specific MS-related symptoms by TMS. Koch et al. demonstrated an improvement of hand dexterity following repetitive TMS, and Centonze and colleagues showed reduced spasticity following TMS.
Read more
Recently, a specific coil for the stimulation of deeper brain regions including the deep nuclei was developed, the so-called H-coil. It successfully stimulates deeper (pre-frontal) brain regions. Stimulation with this coil has been shown to be safe and well tolerated in healthy volunteers, and in patients suffering from major depression.
The aim of this project is to apply deep TMS with the H-coil to the prefrontal cortex (PFC) of MS patients. The PFC is the region at which stimulation is aimed in previous depression studies as this brain region has been shown to play a relevant role in affective disorders. It is the primary aim of this study, to evaluate the safety and tolerability of deep TMS with the H-coil in MS patients with fatigue or depressivity.
- Conditions
- Multiple Sclerosis
- Being tested
- H-coil (Repetitive deep transcranial magnetic stimulation)
- Keywords
- multiple sclerosis, fatigue, depressivity, repetitive deep transcranial magnetic stimulation
- Medical subject headings
- Multiple Sclerosis, Fatigue, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H-coil (Repetitive deep transcranial magnetic stimulation)Device
Also called H-coil (Brainsway LTD., 19 Hartom Str., Jerusalem, Israel)
Repetitive deep transcranial magnetic stimulation of prefrontal cortex or motor cortex or sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| prefrontal cortex (PFC) | Experimental | rTMS with the H-coil to the prefrontal cortex (PFC) Receives: Device: H-coil (Repetitive deep transcranial magnetic stimulation) |
| motor cortex | Active comparator | rTMS with the H-coil to the motor cortex Receives: Device: H-coil (Repetitive deep transcranial magnetic stimulation) |
| sham treatment | Sham comparator | sham treatment Receives: Device: H-coil (Repetitive deep transcranial magnetic stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
examination by physician, assessement of adverse events
Measured: 3x/week during treatment phase
Secondary outcomes (2)
Fatigue
Assessment of Fatigue via Fatigue Severity Scale FSS
Measured: 3x/week during treatment period
Depressivity
Assessment of Depressivity via Beck Depression Inventory BDI
Measured: 3x/week during treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Brainsway
- Responsible party
- Principal investigator, Friedemann Paul, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106365
- Sponsor's protocol ID
- rTMS in MS
- Acronym
- rTMS in MS
- Status last verified
- Jul 2021
- First submitted
- 16 Apr 2010
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Gaede G, Tiede M, Lorenz I, Brandt AU, Pfueller C, Dorr J, Bellmann-Strobl J, Piper SK, Roth Y, Zangen A, Schippling S, Paul F. Safety and preliminary efficacy of deep transcranial magnetic stimulation in MS-related fatigue. Neurol Neuroimmunol Neuroinflamm. 2017 Dec 13;5(1):e423. doi: 10.1212/NXI.0000000000000423. eCollection 2018 Jan.
PubMed 29259998
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Deep Transcranial Magnetic Stimulation in Multiple Sclerosis - A Pilot Study to Evaluate Safety and Efficacy of Deep rTMS on Fatigue and Depressivity in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01106365
- Acronym / sponsor ID
- rTMS in MS / rTMS in MS
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, fatigue, depressivity, repetitive deep transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Brainsway
- Study start
- Feb 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Apr 2010 (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.
Multiple sclerosis (MS) is a chronic-inflammatory autoimmune central nervous system disorder and a leading cause of neurological disability in younger adults in Western countries. Besides "classic" neurological symptoms both depressivity and fatigue are among the most frequent symptoms in MS, affecting up to 90% of patients at onset or during the course of the disease. Neither are the psychological and immunological backgrounds of both well understood, nor are there numerous controlled therapeutic trials which would offer convincing treatment options for fatigue and depressivity in MS.
Transcranial magnetic stimulation (TMS) has been frequently used to investigate altered hemispheric and inter-hemispheric connectivity in MS. Recently, first therapeutic trials have been performed to address specific MS-related symptoms by TMS. Koch et al. demonstrated an improvement of hand dexterity following repetitive TMS, and Centonze and colleagues showed reduced spasticity following TMS.
Recently, a specific coil for the stimulation of deeper brain regions including the deep nuclei was developed, the so-called H-coil. It successfully stimulates deeper (pre-frontal) brain regions. Stimulation with this coil has been shown to be safe and well tolerated in healthy volunteers, and in patients suffering from major depression.
The aim of this project is to apply deep TMS with the H-coil to the prefrontal cortex (PFC) of MS patients. The PFC is the region at which stimulation is aimed in previous depression studies as this brain region has been shown to play a relevant role in affective disorders. It is the primary aim of this study, to evaluate the safety and tolerability of deep TMS with the H-coil in MS patients with fatigue or depressivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| prefrontal cortex (PFC) | Experimental | Device: H-coil (Repetitive deep transcranial magnetic stimulation)rTMS with the H-coil to the prefrontal cortex (PFC) |
| motor cortex | Active comparator | Device: H-coil (Repetitive deep transcranial magnetic stimulation)rTMS with the H-coil to the motor cortex |
| sham treatment | Sham comparator | Device: H-coil (Repetitive deep transcranial magnetic stimulation)sham treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female patients with clinically definite MS according to Polman
- Age 18 to 60
- EDSS 0 to 6
- Relapse-free > 30 days prior to inclusion
- Stable immunomodulatory or immunosuppressive therapy or treatment-naïve for > 3 months prior to inclusion
Key exclusion criteria (15 listed)
- Personal or family history of epilepsy, brain tumor, brain injury
- History of metallic particles in the eye or head outside the mouth
- Cardiac pacemakers, implanted neurostimulators, cochlear implants, implanted medication pumps
- History of drug or alcohol abuse
- Pregnancy
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 |
|---|---|---|
| H-coil (Repetitive deep transcranial magnetic stimulation)Also: H-coil (Brainsway LTD., 19 Hartom Str., Jerusalem, Israel)Repetitive deep transcranial magnetic stimulation of prefrontal cortex or motor cortex or sham stimulation | Device | motor cortex, prefrontal cortex (PFC), sham treatment |
Primary outcome
Safety
Time frame: 3x/week during treatment phase
examination by physician, assessement of adverse events
2 secondary outcomes
Fatigue
Time frame: 3x/week during treatment period
Depressivity
Time frame: 3x/week during treatment period
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 29 Jul 2021.
- Results publication: PubMed 29259998Gaede G, Tiede M, Lorenz I, Brandt AU, Pfueller C, Dorr J, Bellmann-Strobl J, Piper SK, Roth Y, Zangen A, Schippling S, Paul F. Safety and preliminary efficacy of deep transcranial magnetic stimulation in MS-related fatigue. Neurol Neuroimmunol Neuroinflamm. 2017 Dec 13;5(1):e423. doi: 10.1212/NXI.0000000000000423. eCollection 2018 Jan.
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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?
A study testing H-coil (Repetitive deep transcranial magnetic stimulation) in people with Multiple Sclerosis, run by Charite University, Berlin, Germany at 1 site in Germany.
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 9 inclusion and 15 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 29 Jul 2021. 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 Germany. 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. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
Safety (time frame: 3x/week during treatment phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01106365, which also lists 1 linked publication.
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 29 Jul 2021.