BRIEF COMMUNICATIONS AND CASE REPORTS
Failure of Chronic Dorsal Column Stimulation in Multiple Sclerosis
Table 1 . Data on 9 Patients Undergoing Dorsal Colunin Stimulation ~~~
Patient No.
James A. Rosen, MD, and Adib H. Barsoum, MD
In view of the favorable claims of Cook and others, an open trial of chronic dorsal column stimulation was undertaken in 9 patients who had moderately advanced multiple sclerosis (MS) but were still ambulatory. No objective improvement was noted by either author during the postoperative observation period of 6 to 37 months; the occasional subjective improvement was ascribed to placebo effect. This procedure can no longer be recommended for MS patients. Rosen JA, Barsoum AH: Failure of chronic dorsal column stimulation in multiple sclerosis. Ann Neurol6166-67, 1979
Cook [ 31, using dorsal column stimulation techniques devised by Shealy et a1 [ 111, reported considerable improvement in motor and cerebellar performance in patients with multiple sclerosis (MS). Cook and his urological colleagues were particularly impressed by the frequent improvement in bladder function [l]. Neither confirmatory nor contradictory reports on the subject have subsequently appeared.
Materials and Method The efficacy of dorsal column stimulation was tested in 9 patients with MS. To avoid erroneous positive conclusions due to spontaneous remissions or falsely negative impressions due to far-advanced disease, the patients chosen were in the moderately advanced but still ambulatory group [61, corresponding to a McAlpine mobility rating of 3 151. All 9 patients satisfied the Schumachercriteria for the diagnosis of MS [ 9 ] ,and all had defective color vision 171. They had had the disease for at least five years (Table 1) and had shown no remissions or improvement for at least three years prior to surgery. Before and during hospitalization for the surgical procedure, the patients received the maximum tolerated amount of various treatments, including phyical therapy, corticosteroid drugs, antispasticity agents, bladder management, sedation, and immunosuppressant therapy with azathioprine [8]. Informed consent was obtained for t h e surgical procedure.
From the Departments of Neurology and Neurosurgery, University of Pittsburgh School of Medicine, and Westmoreland Hospital, Greensburg, PA. Accepted for publication Dec 19, 1978. Address reprint requests to Dr Rosen, R D #2, Box 645, Greensburg, PA 15601.
~
~
Age at Operation (vr)
Duration of Disease (vr)
39 46 35 54 56 47 37 55 42
16 5 6 5 16 8 5 8 6
Systems Involved
CS, C, S, V, M CS, GU, V
cs, c, v CS, C, GU CS, M
cs, s, v, M CS, C, GU, S
cs, s CS, C. GU, V, M
CS = corticospinal; C = cerebellar; S = sensory; V mental; G U = bladder and sexual.
=
visual; M =
Under general anesthesia, either a low cervical or a high thoracic laminectomy was performed, and a subcutaneous pouch was made for the receiver end of a Medtronic dorsal column stimulator in the pectoral area beneath the left midclavicle. The electrode plate was passed subcutaneously from the subclavicular incision to the thoracic laminectomy incision, and was placed over the exposed dura and anchored in place with silk through the superficial layer of the dura. The stimulator was turned on three to four days later and was deemed to work satisfactorily if the patient experienced paresthesias in the lower extremities. Patients then generally kept the stimulator on during their waking hours. During the observation period after surgery and up to this writing, the patients were evaluated independently by both authors at least once every 6 months and their subjective and objective responses recorded. At each evaluation session the following tests were performed: standard neurological examination 141; color vision testing by H-R-R pseudoisochromatic color plates 171; tandem gait testing over a 10 m course; timed walking with and without assist devices over 20 m; ability to stand up from chair and floor; and cystometrography when bladder improvement was claimed.
Results and Discussion T h e results are recorded in Table 2. The most common subjective indication of improvement was increased exercise and work tolerance. Some patients reported improvement in bladder control, numbness, spastic symptoms, and limb strength. However, neither observer found any objective neurological sign of improvement during the entire postoperative observation period of 6 t o 37 months. The only complication from the procedure was prolonged postoperative psychosis in 1 patient, which subsequently cleared. Considerable discomfort from the laminectomy was common, and a few minor wound infec-
66 0364-5134/791070066-02501.25 @ 1978 by James A. Rosen
Table 2. Results of Dorsal Column Stimulation in 9 Patients Mobility Rating [ 51
Postoperative
FOIIOW-UP
Patient No.
(mo)
Preop.
Present
1 2
10 15
3 3
3 4 5 6
34
2
11
3 3
3 3 3 3 3 3 3 4
7 8
9
13 37 6 8 29
2
3 3 3
D e a d f r o m MS,
Other Objective Improvement
Subjective Improvement
None
None
None None None None None None None None
Marked Moderate Minimal Moderate Worse Worse Minimal None
1978
tions occurred. One stimulator was replaced after several months because of a malfunctioning unit. The patients selected were a valid test group for dorsal column stimulation. Despite the enthusiasm of some patients about the results, the lack of objective improvement represents a negative report on this procedure, and we no longer recommend this procedure for MS patients. Perhaps further experience by others with the operation will clarify the reason for the markedly different results obtained in our study and those previously cited. We note in our results that one-third of the patients experienced moderate o r marked subjective improvement (see Table 2)-exactly the incidence of placebo effect that one should expect from almost any substantial procedure [2, 10, 121. Could this be the explanation for Cook’s results also?
8. Rosen JA: Prolonged azathioprine treatment of non-remitting multiple sclerosis. J Neurol Neurosurg Psychiatry (in press) 9. Schumacher GA, Beebe G, Kibler RF, et al: Problems of experimental trials of therapy in multiple sclerosis. Ann N Y Acad Sci 122:552-568, 1965 10. Shapiro AK: Placebo effects in medicine, psychotherapy, and psychoanalysis, in Bergin AE, Garfield SL (eds): Handbook o n Psychotherapy and Behavioral Change. New York, Aldine, 1971, pp 439-473 11. Shealy CN, Mortimer JT, Hagfors NR: Dorsal column electroanalgesia. J Neurosurg 32:560-566, 1970 12. Wolf S: The pharmacology of placebos. Pharmacol Rev 11:629-704, 1959
We thank Kathy Cannillo, PA, for data collection and patient observation, and Barbara Shoaf for manuscript preparation.
References 1. Abbate AD, Cook AW, Atallah M: Effect of electrical stimulation of the thoracic spinal cord on the function of the bladder in multiple sclerosis. J Urol 117:285-288, 1977 2. Adler HM, Hammett VO: The doctor-patient relationship revisited. Ann Intern Med 78:595-598, 1773 3. Cook AW: Electrical stimulation in multiple sclerosis. Hosp Pract 11:51-58, 1976 4. DeJong RN: The Neurologic Examination. New York, Hoeber, 1950, p 5 5 . McAlpine D , Compston N: Some aspects of the natural history of disseminated sclerosis. Q J Med 21:135-167, 1952 6. Muller R: Course and prognosis of disseminated sclerosis. Arch Neurol Psychiatry 66:561-570, 1751 7. Rosen JA: The use of pseudoisochromatic color plate testing in multiple sclerosis. Trans Am Neurol Assoc 70:283, 1965
Brief Communication: R o s e n and Barsoum: Cord Stimulation Therapy i n MS
67
Failure of Chronic Dorsal Column Stimulation in Multiple Sclerosis
Table 1 . Data on 9 Patients Undergoing Dorsal Colunin Stimulation ~~~
Patient No.
James A. Rosen, MD, and Adib H. Barsoum, MD
In view of the favorable claims of Cook and others, an open trial of chronic dorsal column stimulation was undertaken in 9 patients who had moderately advanced multiple sclerosis (MS) but were still ambulatory. No objective improvement was noted by either author during the postoperative observation period of 6 to 37 months; the occasional subjective improvement was ascribed to placebo effect. This procedure can no longer be recommended for MS patients. Rosen JA, Barsoum AH: Failure of chronic dorsal column stimulation in multiple sclerosis. Ann Neurol6166-67, 1979
Cook [ 31, using dorsal column stimulation techniques devised by Shealy et a1 [ 111, reported considerable improvement in motor and cerebellar performance in patients with multiple sclerosis (MS). Cook and his urological colleagues were particularly impressed by the frequent improvement in bladder function [l]. Neither confirmatory nor contradictory reports on the subject have subsequently appeared.
Materials and Method The efficacy of dorsal column stimulation was tested in 9 patients with MS. To avoid erroneous positive conclusions due to spontaneous remissions or falsely negative impressions due to far-advanced disease, the patients chosen were in the moderately advanced but still ambulatory group [61, corresponding to a McAlpine mobility rating of 3 151. All 9 patients satisfied the Schumachercriteria for the diagnosis of MS [ 9 ] ,and all had defective color vision 171. They had had the disease for at least five years (Table 1) and had shown no remissions or improvement for at least three years prior to surgery. Before and during hospitalization for the surgical procedure, the patients received the maximum tolerated amount of various treatments, including phyical therapy, corticosteroid drugs, antispasticity agents, bladder management, sedation, and immunosuppressant therapy with azathioprine [8]. Informed consent was obtained for t h e surgical procedure.
From the Departments of Neurology and Neurosurgery, University of Pittsburgh School of Medicine, and Westmoreland Hospital, Greensburg, PA. Accepted for publication Dec 19, 1978. Address reprint requests to Dr Rosen, R D #2, Box 645, Greensburg, PA 15601.
~
~
Age at Operation (vr)
Duration of Disease (vr)
39 46 35 54 56 47 37 55 42
16 5 6 5 16 8 5 8 6
Systems Involved
CS, C, S, V, M CS, GU, V
cs, c, v CS, C, GU CS, M
cs, s, v, M CS, C, GU, S
cs, s CS, C. GU, V, M
CS = corticospinal; C = cerebellar; S = sensory; V mental; G U = bladder and sexual.
=
visual; M =
Under general anesthesia, either a low cervical or a high thoracic laminectomy was performed, and a subcutaneous pouch was made for the receiver end of a Medtronic dorsal column stimulator in the pectoral area beneath the left midclavicle. The electrode plate was passed subcutaneously from the subclavicular incision to the thoracic laminectomy incision, and was placed over the exposed dura and anchored in place with silk through the superficial layer of the dura. The stimulator was turned on three to four days later and was deemed to work satisfactorily if the patient experienced paresthesias in the lower extremities. Patients then generally kept the stimulator on during their waking hours. During the observation period after surgery and up to this writing, the patients were evaluated independently by both authors at least once every 6 months and their subjective and objective responses recorded. At each evaluation session the following tests were performed: standard neurological examination 141; color vision testing by H-R-R pseudoisochromatic color plates 171; tandem gait testing over a 10 m course; timed walking with and without assist devices over 20 m; ability to stand up from chair and floor; and cystometrography when bladder improvement was claimed.
Results and Discussion T h e results are recorded in Table 2. The most common subjective indication of improvement was increased exercise and work tolerance. Some patients reported improvement in bladder control, numbness, spastic symptoms, and limb strength. However, neither observer found any objective neurological sign of improvement during the entire postoperative observation period of 6 t o 37 months. The only complication from the procedure was prolonged postoperative psychosis in 1 patient, which subsequently cleared. Considerable discomfort from the laminectomy was common, and a few minor wound infec-
66 0364-5134/791070066-02501.25 @ 1978 by James A. Rosen
Table 2. Results of Dorsal Column Stimulation in 9 Patients Mobility Rating [ 51
Postoperative
FOIIOW-UP
Patient No.
(mo)
Preop.
Present
1 2
10 15
3 3
3 4 5 6
34
2
11
3 3
3 3 3 3 3 3 3 4
7 8
9
13 37 6 8 29
2
3 3 3
D e a d f r o m MS,
Other Objective Improvement
Subjective Improvement
None
None
None None None None None None None None
Marked Moderate Minimal Moderate Worse Worse Minimal None
1978
tions occurred. One stimulator was replaced after several months because of a malfunctioning unit. The patients selected were a valid test group for dorsal column stimulation. Despite the enthusiasm of some patients about the results, the lack of objective improvement represents a negative report on this procedure, and we no longer recommend this procedure for MS patients. Perhaps further experience by others with the operation will clarify the reason for the markedly different results obtained in our study and those previously cited. We note in our results that one-third of the patients experienced moderate o r marked subjective improvement (see Table 2)-exactly the incidence of placebo effect that one should expect from almost any substantial procedure [2, 10, 121. Could this be the explanation for Cook’s results also?
8. Rosen JA: Prolonged azathioprine treatment of non-remitting multiple sclerosis. J Neurol Neurosurg Psychiatry (in press) 9. Schumacher GA, Beebe G, Kibler RF, et al: Problems of experimental trials of therapy in multiple sclerosis. Ann N Y Acad Sci 122:552-568, 1965 10. Shapiro AK: Placebo effects in medicine, psychotherapy, and psychoanalysis, in Bergin AE, Garfield SL (eds): Handbook o n Psychotherapy and Behavioral Change. New York, Aldine, 1971, pp 439-473 11. Shealy CN, Mortimer JT, Hagfors NR: Dorsal column electroanalgesia. J Neurosurg 32:560-566, 1970 12. Wolf S: The pharmacology of placebos. Pharmacol Rev 11:629-704, 1959
We thank Kathy Cannillo, PA, for data collection and patient observation, and Barbara Shoaf for manuscript preparation.
References 1. Abbate AD, Cook AW, Atallah M: Effect of electrical stimulation of the thoracic spinal cord on the function of the bladder in multiple sclerosis. J Urol 117:285-288, 1977 2. Adler HM, Hammett VO: The doctor-patient relationship revisited. Ann Intern Med 78:595-598, 1773 3. Cook AW: Electrical stimulation in multiple sclerosis. Hosp Pract 11:51-58, 1976 4. DeJong RN: The Neurologic Examination. New York, Hoeber, 1950, p 5 5 . McAlpine D , Compston N: Some aspects of the natural history of disseminated sclerosis. Q J Med 21:135-167, 1952 6. Muller R: Course and prognosis of disseminated sclerosis. Arch Neurol Psychiatry 66:561-570, 1751 7. Rosen JA: The use of pseudoisochromatic color plate testing in multiple sclerosis. Trans Am Neurol Assoc 70:283, 1965
Brief Communication: R o s e n and Barsoum: Cord Stimulation Therapy i n MS
67
