Sleep DisorderNCT05599035
Sleep Disorder in Parkinson Disease and rTMS
A study testing repititive transcranial magnetic stimulation in people with Sleep Disorder and Parkinson Disease, run by Assiut University at 1 site in Egypt.
Trial summary
The crude prevalence rate of Parkinson's disease in Upper Egypt governorates ranging from 557-436/100,000 (Assiut and Qena governorates respectively) which was one of the highest prevalence of PD around the world .Parkinson's disease patients report having complaints of disrupted sleep anywhere from 60 to 98 %. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder, Parkinson Disease
- What is being tested?
- repititive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 2 May 2023to 4 Feb 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- diagnosis of PD was done according to UK Brain bank Criteria for diagnosis of PD. Out of them we selected only patients with sleep disturbance All patients fulfilled by Parkinson's disease sleep scale (PDSS).
Who cannot join
- Patients with PD with disturbed conscious level, severe cognitive impairment, psychosis, and medical problems such as (Renal failure, Liver cell Failure, Respiratory Failure, and endocrinal impairment), patients with other types of Parkinsonism as (Multisystem atrophy, supranuclear palsy, and encephalitic Parkinsonism) and patients had contraindication of magnetic stimulation (metallic piece, pacemaker, epilepsy) were also excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
The crude prevalence rate of Parkinson's disease in Upper Egypt governorates ranging from 557-436/100,000 (Assiut and Qena governorates respectively) which was one of the highest prevalence of PD around the world .Parkinson's disease patients report having complaints of disrupted sleep anywhere from 60 to 98 %. This is one of the most common non-motor symptoms, and it is a substantial contributor to the diminished quality of life associated with Parkinson's disease. PD patients have poor sleep maintenance and fragmentation (Comella 2007, Khedr et al. 2013). Khedr et al (2013) found that; 78.6% out of 112 patients with PD had sleep disturbances with the commonest complaint being difficulty getting to sleep at night or staying asleep (46.4%) followed by vivid nightmares and night terrors (27.7%). In other studies, 80-90% of PD patients have had sleep difficulty with virtually all patients having symptoms at some time in the course of the disease .
Read the detailed description
The pathophysiology of PD sleep problems is unclear. Degeneration of major sleep control centers in the brainstem is a leading factor . In addition to dopaminergic medication, nocturnal akinesia, depression and restless legs syndrome, may contribute to sleep disturbances in Parkinson's disease .Previous studies linked dopaminergic impairment in the hypothalamus to sleep disturbances in PD.
Repetitive transcranial magnetic stimulation (rTMS), non-invasive magnetic stimulation of the cerebral cortex is utilized as non-pharmacological therapy in PD with varying degree of results on the motor symptoms. rTMS has also an impact sleep organization in healthy people both during and before sleep.
The effects of rTMS on sleep have been studied in PD in two previous studies, both of which applied HF over either the motor or parietal cortex. They reported improvement in sleep by subjective and objective measures. However, one of the studies found that the improvement seen on polysomnographic (PSG), the other study found improvement in actigraphic recordings. One sham-controlled trial of the effect of rTMS on sleep in patients with PD also revealed substantial placebo-related improvement on subjective questionnaires (i.e., Parkinson Disease Sleep Scale, Hamilton Depression Rating Scale, Unified Parkinson Disease Rating Scale), with sleep improvement found equally between active and sham stimulation groups . Interestingly, in this trial rTMS showed no changes recorded in actigraphy parameters.
Huang et al. 2018 examined the effect of LF rTMS over the parietal cortex in patients who had generalized anxiety disorder with comorbid insomnia and assessed Hamilton Rating Scale for Anxiety (HRS-A), and PSQI. In their trial, PSQI improvements were seen in active rTMS but not in sham stimulation, making this the second trial of a sham-controlled trial without pronounced placebo effect. Additionally, a positive correlation was seen between improvement in the HRSA anxiety scores and PSQI scores which could suggest that sleep improvement was associated with anxiety improvement. It was not known whether the improvement seen in insomnia and anxiety was independent, and whether rTMS really had an intrinsic role in sleep (Rosenquist and McCall 2019) In another study, Jiang et al. 2013 evaluated the effect of rTMS versus medication versus cognitive behavioral therapy in chronic insomnia. They performed the assessments with PSG and PSQI. Based on PSG findings, rTMS only showed superior improvement in stage 3 and rapid-eye movement sleep.
According to the above mentioned studies rTMS seems to have the ability to improve sleep disorders.
The literature in this area remains scarce, with few randomized clinical trials on rTMS and insomnia. Available studies have found mixed results, with some studies reporting subjective sleep improvement while objective improvement is less consistent.
Despite the significant prevalence of sleep disturbances in PD patients, rTMS's influence on sleep has not been objectively evaluated. To date, the exact mechanism by which rTMS is thought to influence sleep has yet to be fully explained particulary in PD.
The present study aimed to analyse the sleep disturbance in PD patients compared with normal volunteers and to objectively evaluate if rTMS has impact on sleep disorders or not in patients with PD.
- Conditions
- Sleep Disorder, Parkinson Disease
- Being tested
- repititive transcranial magnetic stimulation
- Keywords
- sleep disorder Parkinson disease, rTMS
- Medical subject headings
- Sleep Wake Disorders, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repititive transcranial magnetic stimulationDevice
a figure-of-8 coil (7-cm diameter loop) positioned over the parietal area for ten sessions (10 trains, with frequency of stimulation 20-Hz, each lasting for 10 seconds with an inter-train interval of 30 seconds. The intensity of stimulation was set at 80% of the RMT for the first dorsal interosseous (FDI) of the contralateral hand with a total 2000 pulses for each parietal area.)
| Study group | Role | What they receive |
|---|---|---|
| 1st group received active rTMS, | Active comparator | Active rTMS was applied using a figure-of-8 coil (7-cm diameter loop) positioned over the parietal area for ten sessions (10 trains, with frequency of stimulation 20-Hz, each lasting for 10 seconds with an inter-train interval of 30 seconds. The intensity of stimulation was set at 80% of the RMT for the first dorsal interosseous (FDI) of the contralateral hand with a total 2000 pulses for each hemisphere). Each patient received five sessions /week for two consecutive weeks with ten total sessions over the parietal area. The parietal region was determined according to the 10-20 system for electroencephalographic electrode positioning at P3 and P4, respectively. Receives: Device: repititive transcranial magnetic stimulation |
| 2nd group was the sham group | Sham comparator | rTMS was applied using the same parameters, but with the coil edge was applied perpendicular to the scalp in the sagittal plane jut to reproduce the noise of the stimulation Receives: Device: repititive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parkinson's disease sleep scale (PDSS)
The PDSS is a visual analogue scale addressing 15 commonly reported symptoms associated with sleep disturbance overall quality of night's sleep (item 1); • sleep onset and maintenance insomnia (items 2 and 3); • nocturnal restlessness (items 4 and 5); • nocturnal psychosis (items 6 and 7) • nocturia (items 8 and 9); • nocturnal motor symptoms (items 10-13); • sleep refreshment (item 14); • daytime dozing (item 15).
Measured: 1 month
polysomenography
This polysomnography systematically monitored the electroencephalogram (EEG) (C3-A2, C4-A1), electrooculogram (EOG), electromyogram of the chin (EMG), electrocardiogram (EKG), body positions, nasal and oral airflow, thoracic and abdominal effort, limb movements, pulse oximetry, and snoring sound level.
Measured: 1 month
Secondary outcomes (3)
Beck Depression Inventory
It is a 21-question multiple-choice self-report inventory, one of the most widely used for measurment severity of depression the BDI-II also contains about 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used differ from the original:
0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression
Measured: 1 month
Unified Parkinson's Disease Rating Scale (UPDRS)
it is a rating scale for assessment of motor and non-motor functions in PD. This assessment included in 4 parts: Part I contains mental section consisting of 4 items (intellectual impairment, thought disorder, depression and motivation), part II consists of activities of daily life with the 12 questions covering many activities like hygiene, dressing, writing and freezing during walking, part III consists of the motor clinical assessment with 14 items (speech, facial expression, tremors at rest, action tremor, rigidity, finger taps, hand movement, rapid alternating movements of hands, leg agility, arising from chair, posture, gait, postural stability, bradykinesia), while part IV is addition of drug complications (dyskinesia, clinical fluctuations). We used motor clinical assessment part III in which each item ranked from 0 (normal), 1 (mildly impaired), 2 (moderately impaired), 3 (severely impaired), 4 (can barely perform the task).
Measured: 1 month
Cognitive assessment using Montreal Cognitive assessment
score 0-30
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start2 May 2023
- Primary completion5 Jan 2024
- Study completion4 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Assiut 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study included 30 PD patients and 20 normal volunteers' age and sex matched that were recruited .The diagnosis of PD was done according to UK Brain bank Criteria for diagnosis of PD. Out of them we selected only patients with sleep disturbance according to Self-reported questionnaire for non-motor symptoms (sleep disturbance section; Question 23, 24, 25, 26 as follow 23-Difficulty getting to sleep at night or staying asleep at night 24. Intense, vivid dreams or frightening dreams. 25. Talking or moving about in your sleep as if you are 'acting out' a dream 26. Unpleasant sensations in your legs at night or while resting, and a feeling that you need to move.,) (NMSQuest) or frightening dreams All patients fulfilled by Parkinson's disease sleep scale (PDSS). Treatment was maintained constant during the trial. Each patient under levodopa (Sinemet 250/25; ½ table 3 times per day) and anticholinergic (cogenitol ½ table 3 times per day).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman M. Khedr, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599035
- Sponsor's protocol ID
- sleep disorder in parkinson
- Status last verified
- Jan 2024
- First submitted
- 25 Oct 2022
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Oerlemans WG, de Weerd AW. The prevalence of sleep disorders in patients with Parkinson's disease. A self-reported, community-based survey. Sleep Med. 2002 Mar;3(2):147-9. doi: 10.1016/s1389-9457(01)00127-7.
PubMed 14592234Chaudhuri KR, Yates L, Martinez-Martin P. The non-motor symptom complex of Parkinson's disease: a comprehensive assessment is essential. Curr Neurol Neurosci Rep. 2005 Jul;5(4):275-83. doi: 10.1007/s11910-005-0072-6.
PubMed 15987611Arias P, Vivas J, Grieve KL, Cudeiro J. Double-blind, randomized, placebo controlled trial on the effect of 10 days low-frequency rTMS over the vertex on sleep in Parkinson's disease. Sleep Med. 2010 Sep;11(8):759-65. doi: 10.1016/j.sleep.2010.05.003. Epub 2010 Jul 31.
PubMed 20674489Khedr EM, Farweez HM, Islam H. Therapeutic effect of repetitive transcranial magnetic stimulation on motor function in Parkinson's disease patients. Eur J Neurol. 2003 Sep;10(5):567-72. doi: 10.1046/j.1468-1331.2003.00649.x.
PubMed 12940840Khedr EM, Fawi G, Abbas MA, Mohammed TA, El-Fetoh NA, Attar GA, Zaki AF. Prevalence of Parkinsonism and Parkinson's disease in Qena governorate/Egypt: a cross-sectional community-based survey. Neurol Res. 2015 Jul;37(7):607-18. doi: 10.1179/1743132815Y.0000000020. Epub 2015 Mar 23.
PubMed 25796953Khedr EM, Al Attar GS, Kandil MR, Kamel NF, Abo Elfetoh N, Ahmed MA. Epidemiological study and clinical profile of Parkinson's disease in the Assiut Governorate, Egypt: a community-based study. Neuroepidemiology. 2012;38(3):154-63. doi: 10.1159/000335701. Epub 2012 Mar 29.
PubMed 22473384Khedr EM, El Fetoh NA, Khalifa H, Ahmed MA, El Beh KM. Prevalence of non motor features in a cohort of Parkinson's disease patients. Clin Neurol Neurosurg. 2013 Jun;115(6):673-7. doi: 10.1016/j.clineuro.2012.07.032. Epub 2012 Aug 16.
PubMed 22902078
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disorder in Parkinson Disease and rTMS
- ClinicalTrials.gov ID
- NCT05599035
- Acronym / sponsor ID
- sleep disorder in parkinson
- Conditions
- Sleep Disorder, Parkinson Disease
- Keywords
- sleep disorder Parkinson disease, rTMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 4 Feb 2024 (actual)
- First posted
- 31 Oct 2022 (actual)
- 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.
The crude prevalence rate of Parkinson's disease in Upper Egypt governorates ranging from 557-436/100,000 (Assiut and Qena governorates respectively) which was one of the highest prevalence of PD around the world .Parkinson's disease patients report having complaints of disrupted sleep anywhere from 60 to 98 %. This is one of the most common non-motor symptoms, and it is a substantial contributor to the diminished quality of life associated with Parkinson's disease. PD patients have poor sleep maintenance and fragmentation (Comella 2007, Khedr et al. 2013). Khedr et al (2013) found that; 78.6% out of 112 patients with PD had sleep disturbances with the commonest complaint being difficulty getting to sleep at night or staying asleep (46.4%) followed by vivid nightmares and night terrors (27.7%). In other studies, 80-90% of PD patients have had sleep difficulty with virtually all patients having symptoms at some time in the course of the disease .
Detailed description
The pathophysiology of PD sleep problems is unclear. Degeneration of major sleep control centers in the brainstem is a leading factor . In addition to dopaminergic medication, nocturnal akinesia, depression and restless legs syndrome, may contribute to sleep disturbances in Parkinson's disease .Previous studies linked dopaminergic impairment in the hypothalamus to sleep disturbances in PD.
Repetitive transcranial magnetic stimulation (rTMS), non-invasive magnetic stimulation of the cerebral cortex is utilized as non-pharmacological therapy in PD with varying degree of results on the motor symptoms. rTMS has also an impact sleep organization in healthy people both during and before sleep.
The effects of rTMS on sleep have been studied in PD in two previous studies, both of which applied HF over either the motor or parietal cortex. They reported improvement in sleep by subjective and objective measures. However, one of the studies found that the improvement seen on polysomnographic (PSG), the other study found improvement in actigraphic recordings. One sham-controlled trial of the effect of rTMS on sleep in patients with PD also revealed substantial placebo-related improvement on subjective questionnaires (i.e., Parkinson Disease Sleep Scale, Hamilton Depression Rating Scale, Unified Parkinson Disease Rating Scale), with sleep improvement found equally between active and sham stimulation groups . Interestingly, in this trial rTMS showed no changes recorded in actigraphy parameters.
Huang et al. 2018 examined the effect of LF rTMS over the parietal cortex in patients who had generalized anxiety disorder with comorbid insomnia and assessed Hamilton Rating Scale for Anxiety (HRS-A), and PSQI. In their trial, PSQI improvements were seen in active rTMS but not in sham stimulation, making this the second trial of a sham-controlled trial without pronounced placebo effect. Additionally, a positive correlation was seen between improvement in the HRSA anxiety scores and PSQI scores which could suggest that sleep improvement was associated with anxiety improvement. It was not known whether the improvement seen in insomnia and anxiety was independent, and whether rTMS really had an intrinsic role in sleep (Rosenquist and McCall 2019) In another study, Jiang et al. 2013 evaluated the effect of rTMS versus medication versus cognitive behavioral therapy in chronic insomnia. They performed the assessments with PSG and PSQI. Based on PSG findings, rTMS only showed superior improvement in stage 3 and rapid-eye movement sleep.
According to the above mentioned studies rTMS seems to have the ability to improve sleep disorders.
The literature in this area remains scarce, with few randomized clinical trials on rTMS and insomnia. Available studies have found mixed results, with some studies reporting subjective sleep improvement while objective improvement is less consistent.
Despite the significant prevalence of sleep disturbances in PD patients, rTMS's influence on sleep has not been objectively evaluated. To date, the exact mechanism by which rTMS is thought to influence sleep has yet to be fully explained particulary in PD.
The present study aimed to analyse the sleep disturbance in PD patients compared with normal volunteers and to objectively evaluate if rTMS has impact on sleep disorders or not in patients with PD.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study included 30 PD patients and 20 normal volunteers' age and sex matched that were recruited .The diagnosis of PD was done according to UK Brain bank Criteria for diagnosis of PD. Out of them we selected only patients with sleep disturbance according to Self-reported questionnaire for non-motor symptoms (sleep disturbance section; Question 23, 24, 25, 26 as follow 23-Difficulty getting to sleep at night or staying asleep at night 24. Intense, vivid dreams or frightening dreams. 25. Talking or moving about in your sleep as if you are 'acting out' a dream 26. Unpleasant sensations in your legs at night or while resting, and a feeling that you need to move.,) (NMSQuest) or frightening dreams All patients fulfilled by Parkinson's disease sleep scale (PDSS). Treatment was maintained constant during the trial. Each patient under levodopa (Sinemet 250/25; ½ table 3 times per day) and anticholinergic (cogenitol ½ table 3 times per day).
| Arm | Type | Receives |
|---|---|---|
| 1st group received active rTMS, | Active comparator | Device: repititive transcranial magnetic stimulationActive rTMS was applied using a figure-of-8 coil (7-cm diameter loop) positioned over the parietal area for ten sessions (10 trains, with frequency of stimulation 20-Hz, each lasting for 10 seconds with an inter-train interval of 30 seconds. The intensity of stimulation was set at 80% of the RMT for the first dorsal interosseous (FDI) of the contralateral hand with a total 2000 pulses for each hemisphere). Each patient received five sessions /week for two consecutive weeks with ten total sessions over the parietal area. The parietal region was determined according to the 10-20 system for electroencephalographic electrode positioning at P3 and P4, respectively. |
| 2nd group was the sham group | Sham comparator | Device: repititive transcranial magnetic stimulationrTMS was applied using the same parameters, but with the coil edge was applied perpendicular to the scalp in the sagittal plane jut to reproduce the noise of the stimulation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of PD was done according to UK Brain bank Criteria for diagnosis of PD. Out of them we selected only patients with sleep disturbance All patients fulfilled by Parkinson's disease sleep scale (PDSS).
Key exclusion criteria (1 listed)
- Patients with PD with disturbed conscious level, severe cognitive impairment, psychosis, and medical problems such as (Renal failure, Liver cell Failure, Respiratory Failure, and endocrinal impairment), patients with other types of Parkinsonism as (Multisystem atrophy, supranuclear palsy, and encephalitic Parkinsonism) and patients had contraindication of magnetic stimulation (metallic piece, pacemaker, epilepsy) were also excluded from the study
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 |
|---|---|---|
| repititive transcranial magnetic stimulationa figure-of-8 coil (7-cm diameter loop) positioned over the parietal area for ten sessions (10 trains, with frequency of stimulation 20-Hz, each lasting for 10 seconds with an inter-train interval of 30 seconds. The intensity of stimulation was set at 80% of the RMT for the first dorsal interosseous (FDI) of the contralateral hand with a total 2000 pulses for each parietal area.) | Device | 1st group received active rTMS,, 2nd group was the sham group |
Primary outcome
Parkinson's disease sleep scale (PDSS)
Time frame: 1 month
The PDSS is a visual analogue scale addressing 15 commonly reported symptoms associated with sleep disturbance overall quality of night's sleep (item 1); • sleep onset and maintenance insomnia (items 2 and 3); • nocturnal restlessness (items 4 and 5); • nocturnal psychosis (items 6 and 7) • nocturia (items 8 and 9); • nocturnal motor symptoms (items 10-13); • sleep refreshment (item 14); • daytime dozing (item 15).
polysomenography
Time frame: 1 month
This polysomnography systematically monitored the electroencephalogram (EEG) (C3-A2, C4-A1), electrooculogram (EOG), electromyogram of the chin (EMG), electrocardiogram (EKG), body positions, nasal and oral airflow, thoracic and abdominal effort, limb movements, pulse oximetry, and snoring sound level.
3 secondary outcomes
Beck Depression Inventory
Time frame: 1 month
Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: 1 month
Cognitive assessment using Montreal Cognitive assessment
Time frame: 1 month
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 Apr 2024.
- Background: PubMed 14592234Oerlemans WG, de Weerd AW. The prevalence of sleep disorders in patients with Parkinson's disease. A self-reported, community-based survey. Sleep Med. 2002 Mar;3(2):147-9. doi: 10.1016/s1389-9457(01)00127-7.
- Background: PubMed 15987611Chaudhuri KR, Yates L, Martinez-Martin P. The non-motor symptom complex of Parkinson's disease: a comprehensive assessment is essential. Curr Neurol Neurosci Rep. 2005 Jul;5(4):275-83. doi: 10.1007/s11910-005-0072-6.
- Background: PubMed 20674489Arias P, Vivas J, Grieve KL, Cudeiro J. Double-blind, randomized, placebo controlled trial on the effect of 10 days low-frequency rTMS over the vertex on sleep in Parkinson's disease. Sleep Med. 2010 Sep;11(8):759-65. doi: 10.1016/j.sleep.2010.05.003. Epub 2010 Jul 31.
- Background: PubMed 12940840Khedr EM, Farweez HM, Islam H. Therapeutic effect of repetitive transcranial magnetic stimulation on motor function in Parkinson's disease patients. Eur J Neurol. 2003 Sep;10(5):567-72. doi: 10.1046/j.1468-1331.2003.00649.x.
- Background: PubMed 25796953Khedr EM, Fawi G, Abbas MA, Mohammed TA, El-Fetoh NA, Attar GA, Zaki AF. Prevalence of Parkinsonism and Parkinson's disease in Qena governorate/Egypt: a cross-sectional community-based survey. Neurol Res. 2015 Jul;37(7):607-18. doi: 10.1179/1743132815Y.0000000020. Epub 2015 Mar 23.
- Background: PubMed 22473384Khedr EM, Al Attar GS, Kandil MR, Kamel NF, Abo Elfetoh N, Ahmed MA. Epidemiological study and clinical profile of Parkinson's disease in the Assiut Governorate, Egypt: a community-based study. Neuroepidemiology. 2012;38(3):154-63. doi: 10.1159/000335701. Epub 2012 Mar 29.
- Background: PubMed 22902078Khedr EM, El Fetoh NA, Khalifa H, Ahmed MA, El Beh KM. Prevalence of non motor features in a cohort of Parkinson's disease patients. Clin Neurol Neurosurg. 2013 Jun;115(6):673-7. doi: 10.1016/j.clineuro.2012.07.032. Epub 2012 Aug 16.
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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 repititive transcranial magnetic stimulation in people with Sleep Disorder and Parkinson Disease, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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 Apr 2024. 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 Egypt. 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?
Parkinson's disease sleep scale (PDSS) (time frame: 1 month). The study lists 2 primary outcomes in all. 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 NCT05599035, which also lists 7 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 Apr 2024.