The Influence of Low Frequency Repetitive Transcranial Stimulation (r-TMS) on Motor and Cognitive Measurements in Patients With Asymmetric Parkinson's Disease

UPDRS Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01016743
• Other study ID #: SHEBA-09-7279-OC-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: November 18, 2009
• Last updated: November 18, 2009
• Start date: November 2009

Study information

• Verified date: November 2009
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

To test the effects of low frequency deep rTMS using the novel H-coil on the motor, affective and cognitive deficits in patients with asymmetric Parkinson's disease (PD) and to establish its safety in this population. The investigators anticipate that reaching deeper brain layers and larger volume of activation with the novel H-coil may induce significantly better therapeutic effects in patients with PD and will pave the way for establishing a novel and effective treatment for this disorder.

Description:

PD patients with asymmetric disease aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria, with Hoehn & Yahr stages II - IV while "off" will be recruited. Participants on antidepressants should be at least 2 months on stable therapy.

Patient will be excluded if:

1. They have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative.

2. Are on neuroleptics.

3. Have dementia or any unstable medical disorder.

4. Have a history or current unstable hypertension.

5. Have a history of head injury or neurosurgical interventions.

6. Have a history of any metal in the head (outside the mouth).

7. Have a known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.

Patients will be randomized into two groups: The first group of patients will receive an active unilateral stimulation over the motor cortex contralateral to the more affected body side (1Hz stimulation 110% of the MT for 15 minutes). Patients in the second group will receive a similar rTMS stimulation pattern over the motor cortex and over the prefrontal cortex (10Hz stimulation 100% of the MT, 2 seconds each train, 20 seconds between trains, for 15 minutes).

The following outcome measures will be taken prior to the treatment (screening visit), and at day 1, 10, 30 and 60 Evaluation will be while subjects both at "on" and "off".

Motor:

1. Unified Parkinson's Disease Rating Scale (UPDRS )

2. Clinical Global Impression of Severity (CGIS)

3. Pegboard test.

4. Tapping test

5. Up & Go test

6. Abnormal Involuntary Movement Scale (AIMS) Mood and affect

1. Beck Depression Inventory (BDI) Cognition

1. Mini mental State examination (MMSE)

2. Digit forward and backward tests.

3. Word fluency.

4. Frontal Assessment Battery (FAB) Side effects will be closely monitored by the researchers and will be promptly reported to the IRB.

8.Have a history of migraine or frequent or severe headaches. 9.Have a history of hearing loss. 10.Has a of cochlear implants 11.Have a history of drug abuse or alcoholism. 12.Is pregnant or not using a reliable method of birth control. 13.Is participating in current clinical study or clinical study within 30 days prior to this study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• PD patients with asymmetric disease aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria, with Hoehn & Yahr stages II - IV while "off".

• Participants on antidepressants should be at least 2 months on stable therapy.

Exclusion Criteria:

• Patients who have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative.

• Patients on neuroleptics.

• Patients with dementia or any unstable medical disorder.

• History or current unstable hypertension.

• History of head injury or neurosurgical interventions.

• History of any metal in the head (outside the mouth).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• UPDRS

Intervention

Device:
• repetitive transcranial stimulation (r-TMS)
Patients will be randomized into two groups: The first group of patients will receive an active unilateral stimulation over the motor cortex contralateral to the more affected body side (1Hz stimulation 110% of the MT for 15 minutes). Patients in the second group will receive a similar rTMS stimulation pattern over the motor cortex and over the prefrontal cortex (10Hz stimulation 100% of the MT, 2 seconds each train, 20 seconds between trains, for 15 minutes).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unified Parkinson's Disease Rating Scale (UPDRS )		1 year	No
Secondary	CGIS,Pegboard test.Tapping test,Up&Go test,AIMS,BDI,MMSE,Word fluencyFAB		1 year	No
Secondary	UPDRS		3 months	No